RALOX or CAPOX + Bevacizumab in the First-line Treatment of Advanced CRC(ROCB Study)

NCT03813641 | Unknown Phase 2

• 1 other identifier: Shenzhen CRC-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Raltitrexed is an inhibitor of thymidylate synthase.As a folate antimetabolite drug, raltitrexed has been used in treatment of colorectal cancer(CRC) since 1998, and also used in malignant mesothelioma.Several phase III studies performed in patients with advanced CRC showed that it is as effective as 5-fluorouracil(5-FU) /leucovorin(LV) with regard to response rates and survival. The combination of raltitrexed with oxaliplatin shows response rates of 41%-54% and median survivals of 14.6-14.8 months, which are comparable to those achieved with 5-FU/LV combination with oxaliplatin. This study discussed the efficacy and safety of raltitrexed-oxaliplatin(RALOX) combined with bevacizumab or capecitabine-oxaliplatin(CAPOX) combined with bevacizumab in first-line treatment of patients with advanced colorectal cancer who could not undergo radical surgery. The main endpoint will be progression free survival (PFS). The secondary endpoints will be overall survival, objective response rate and disease control rate (OS,ORR and DCR).It is expected that raltitrexed may be one of options for the treatment of advanced CRC in the first-line setting.

Conditions

Colorectal Cancer

Keywords

Raltitrexed; First-line therapy; Bevacizumab; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) Time

  PFS is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) \[according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1\] or death due to any cause, whichever will be first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression will be considered to have progressed on the day of their death. Participants who do not progress or be lost to follow-up will be censored at the day of their last radiographic tumor assessment.

  The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years.

Secondary Outcomes (3)

• Overall Survival (OS)

  The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission,up to 2 years.

• Percentage of Participants Achieving an Objective Response (Objective Response Rate)

  The follow-up period ranges from the first patient recruited to the last patient within 3 months after admission.

• Percentage of Participants Achieving a Stable Disease (SD) or a confirmed CR or PR (Disease Control Rate)

  The follow-up period ranges from the first patient recruited to the last patient within 3 months after admission.

Study Arms (2)

RALOX + bevacizumab

EXPERIMENTAL

Oxaliplatin 130mg/m2, i.v.gtt 2h, d1 Raltitrexed 3mg/m2, i.v.gtt 15min ,d1 Bevacizumab 7.5mg/kg, i.v.gtt, d1 The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to raltitrexed (3mg/m2, intravenous drip for 15 minutes, d1)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.

Drug: Raltitrexed

CAPOX + bevacizumab

ACTIVE COMPARATOR

Oxaliplatin 130mg/m2, i.v.gtt 2h, d1 Capecitabine 1000mg/m2, po. ,d1 Bevacizumab 7.5mg/kg, i.v.gtt, d1 The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Capecitabine (1000mg/m2 po. d1-14)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.

Drug: Capecitabine

Interventions

Raltitrexed DRUG

Experimental: Oxaliplatin + Raltitrexed + Bevacizumab The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Raltitrexed (3mg/m2, intravenous drip for 15 minutes, d1)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.

Also known as: Tomudex

RALOX + bevacizumab

Capecitabine DRUG

Other: Oxaliplatin + Capecitabine + Bevacizumab The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Capecitabine (1000mg/m2 po. d1-14)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.

Also known as: Xeloda

CAPOX + bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18\~75 years;
• Patients are diagnosed by histopathological and/or cytological examination as local advanced or metastatic colorectal cancer who are unable to undergo radical surgery with no symptom of the primary lesions；
• There are one or more measurable lesions, the longest diameter of which is at least 10 mm by spiral CT scanning (RECIST standard, version 1.1)
• ECOG performance status (ECOG PS) 0\~1;
• Life expectancy not less than 3 month
• Blood routine, liver and kidney function reached the following criteria within 14 days before screening:
• Absolute neutrophil count (\> 1.5x109/L); hemoglobin (\> 9.0 g/dl); platelet count (\> 100 x109/L); total bilirubin (\< 1.5 times the normal upper limit (ULN); alanine aminotransferase and glutamic oxaloacetate aminotransferase (\< 2.5 x ULN) in patients with liver metastasis (\< 5 x ULN); alkaline phosphatase （\< 3 x ULN（ in patients with liver metastasis \< 5 x ULN)）; serum creatinine （\< 1.5 x ULN）;
• Adequate blood coagulation function \[International Normalized Ratio (INR) ≤1.5 and Partial Thromboplastin Time (PTT) or activated PTT (aPTT) ≤1.5 x upper limit of normal (ULN)). Participants on full-dose anticoagulation must be in a stable phase of anticoagulant therapy and if taking oral anticoagulation, participants must have an INR ≤3 without clinically significant active bleeding or a high risk of bleeding.
• Agree to provide histological specimens from previous operations for biomarker assessment and specimens remain。
• Signed informed consent to be provided

You may not qualify if:

• Previous treatment with Raltitrexed；
• With a large amount of pleural effusions or ascites requiring puncture drainage；
• Active clinical severe infections include hepatitis；
• One of the following complications: 1) Gastrointestinal obstruction (including paralytic ileus) or gastrointestinal bleeding 2) Symptomatic cardiac disease (including unstable angina, myocardial infarction, and heart failure) 3) Pulmonary fibrosis or interstitial pneumonia 4) Uncontrolled diabetes mellitus 5) Uncontrolled diarrhea (that affects daily activities although adequate therapy )
• Symptomatic brain or meningeal metastasis (unless the patient has been treated for \> 6 months, the imaging results are negative in the 4 weeks before entering the study, and the clinical symptoms associated with the tumor are stable at the time of entering the study);
• Undergoing kidney dialysis；
• History of other malignant tumors within 5 years, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin;
• Drug abuse and medical, psychological or social conditions may interfere with patients' participation in the study or have an impact on the evaluation of the study results；
• Pregnant or lactating females, and males and females reluctant to use contraception
• History of concurrent gastrointestinal perforation or gastrointestinal perforation within 1 year prior to enrollment
• Pulmonary hemorrhage/hemoptysis ≥ Grade 2 (identified as bright red blood of not less 2.5mL) within 1 month before enrollment.
• History of thoracotomy,laparotomy, or intestinal resection within 28 days prior to enrollment;
• Unhealed wound (other than suture wounds due to implantation of a central venous port), traumatic fracture, or gastrointestinal ulcer
• Current cerebrovascular disease or thromboembolism or either within 1 year before enrollment
• Current anticoagulation therapy or requiring anticoagulation agents (\> 325 mg/day of aspirin)

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, China

RECRUITING

Related Publications (34)

• Kindler HL, Shulman KL. Metastatic colorectal cancer. Curr Treat Options Oncol. 2001 Dec;2(6):459-71. doi: 10.1007/s11864-001-0068-7.

  PMID: 12057092 BACKGROUND

• Meta-analysis Group In Cancer; Piedbois P, Rougier P, Buyse M, Pignon J, Ryan L, Hansen R, Zee B, Weinerman B, Pater J, Leichman C, Macdonald J, Benedetti J, Lokich J, Fryer J, Brufman G, Isacson R, Laplanche A, Levy E. Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer. J Clin Oncol. 1998 Jan;16(1):301-8. doi: 10.1200/JCO.1998.16.1.301.

  PMID: 9440757 BACKGROUND

• Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. Advanced Colorectal Cancer Meta-Analysis Project. J Clin Oncol. 1992 Jun;10(6):896-903. doi: 10.1200/JCO.1992.10.6.896.

  PMID: 1534121 BACKGROUND

• Meta-Analysis Group In Cancer; Levy E, Piedbois P, Buyse M, Pignon JP, Rougier P, Ryan L, Hansen R, Zee B, Weinerman B, Pater J, Leichman C, Macdonald J, Benedetti J, Lokich J, Fryer J, Brufman G, Isacson R, Laplanche A, Quinaux E, Thirion P. Toxicity of fluorouracil in patients with advanced colorectal cancer: effect of administration schedule and prognostic factors. J Clin Oncol. 1998 Nov;16(11):3537-41. doi: 10.1200/JCO.1998.16.11.3537.

  PMID: 9817272 BACKGROUND

• Becker K, Erckenbrecht JF, Haussinger D, Frieling T. Cardiotoxicity of the antiproliferative compound fluorouracil. Drugs. 1999 Apr;57(4):475-84. doi: 10.2165/00003495-199957040-00003.

  PMID: 10235688 BACKGROUND

• Wacker A, Lersch C, Scherpinski U, Reindl L, Seyfarth M. High incidence of angina pectoris in patients treated with 5-fluorouracil. A planned surveillance study with 102 patients. Oncology. 2003;65(2):108-12. doi: 10.1159/000072334.

  PMID: 12931015 BACKGROUND

• Rougier P, Van Cutsem E, Bajetta E, Niederle N, Possinger K, Labianca R, Navarro M, Morant R, Bleiberg H, Wils J, Awad L, Herait P, Jacques C. Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet. 1998 Oct 31;352(9138):1407-12. doi: 10.1016/S0140-6736(98)03085-2.

  PMID: 9807986 BACKGROUND

• Cunningham D, Pyrhonen S, James RD, Punt CJ, Hickish TF, Heikkila R, Johannesen TB, Starkhammar H, Topham CA, Awad L, Jacques C, Herait P. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet. 1998 Oct 31;352(9138):1413-8. doi: 10.1016/S0140-6736(98)02309-5.

  PMID: 9807987 BACKGROUND

• Seymour MT, Maughan TS, Ledermann JA, Topham C, James R, Gwyther SJ, Smith DB, Shepherd S, Maraveyas A, Ferry DR, Meade AM, Thompson L, Griffiths GO, Parmar MK, Stephens RJ; FOCUS Trial Investigators; National Cancer Research Institute Colorectal Clinical Studies Group. Different strategies of sequential and combination chemotherapy for patients with poor prognosis advanced colorectal cancer (MRC FOCUS): a randomised controlled trial. Lancet. 2007 Jul 14;370(9582):143-152. doi: 10.1016/S0140-6736(07)61087-3.

  PMID: 17630037 BACKGROUND

• Graeven U, Arnold D, Reinacher-Schick A, Heuer T, Nusch A, Porschen R, Schmiegel W. A randomised phase II study of irinotecan in combination with 5-FU/FA compared with irinotecan alone as second-line treatment of patients with metastatic colorectal carcinoma. Onkologie. 2007 Apr;30(4):169-74. doi: 10.1159/000099636. Epub 2007 Mar 23.

  PMID: 17396039 BACKGROUND

• Leonard P, Seymour MT, James R, Hochhauser D, Ledermann JA. Phase II study of irinotecan with bolus and high dose infusional 5-FU and folinic acid (modified de Gramont) for first or second line treatment of advanced or metastatic colorectal cancer. Br J Cancer. 2002 Nov 18;87(11):1216-20. doi: 10.1038/sj.bjc.6600641.

  PMID: 12439708 BACKGROUND

• Rougier P, Lepille D, Bennouna J, Marre A, Ducreux M, Mignot L, Hua A, Mery-Mignard D. Antitumour activity of three second-line treatment combinations in patients with metastatic colorectal cancer after optimal 5-FU regimen failure: a randomised, multicentre phase II study. Ann Oncol. 2002 Oct;13(10):1558-67. doi: 10.1093/annonc/mdf259.

  PMID: 12377643 BACKGROUND

• Peeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, Andre T, Chan E, Lordick F, Punt CJ, Strickland AH, Wilson G, Ciuleanu TE, Roman L, Van Cutsem E, Tzekova V, Collins S, Oliner KS, Rong A, Gansert J. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol. 2010 Nov 1;28(31):4706-13. doi: 10.1200/JCO.2009.27.6055. Epub 2010 Oct 4.

  PMID: 20921462 BACKGROUND

• Fuchs CS, Marshall J, Mitchell E, Wierzbicki R, Ganju V, Jeffery M, Schulz J, Richards D, Soufi-Mahjoubi R, Wang B, Barrueco J. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: results from the BICC-C Study. J Clin Oncol. 2007 Oct 20;25(30):4779-86. doi: 10.1200/JCO.2007.11.3357.

  PMID: 17947725 BACKGROUND

• Tournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004 Jan 15;22(2):229-37. doi: 10.1200/JCO.2004.05.113. Epub 2003 Dec 2.

  PMID: 14657227 BACKGROUND

• Jarmula A. Antifolate inhibitors of thymidylate synthase as anticancer drugs. Mini Rev Med Chem. 2010 Nov;10(13):1211-22. doi: 10.2174/13895575110091211.

  PMID: 20854257 BACKGROUND

• Wilson KS, Malfair Taylor SC. Raltitrexed: optimism and reality. Expert Opin Drug Metab Toxicol. 2009 Nov;5(11):1447-54. doi: 10.1517/17425250903307455.

  PMID: 19863453 BACKGROUND

• Cunningham D. Mature results from three large controlled studies with raltitrexed ('Tomudex'). Br J Cancer. 1998;77 Suppl 2(Suppl 2):15-21. doi: 10.1038/bjc.1998.421.

  PMID: 9579851 BACKGROUND

• Cocconi G, Cunningham D, Van Cutsem E, Francois E, Gustavsson B, van Hazel G, Kerr D, Possinger K, Hietschold SM. Open, randomized, multicenter trial of raltitrexed versus fluorouracil plus high-dose leucovorin in patients with advanced colorectal cancer. Tomudex Colorectal Cancer Study Group. J Clin Oncol. 1998 Sep;16(9):2943-52. doi: 10.1200/JCO.1998.16.9.2943.

  PMID: 9738562 BACKGROUND

• Feliu J, Mel JR, Camps C, Escudero P, Aparicio J, Menendez D, Garcia Giron C, Rodriguez MR, Sanchez JJ, Gonzalez Baron M; Oncopaz Cooperative Group Associated Hospitals. Raltitrexed in the treatment of elderly patients with advanced colorectal cancer: an active and low toxicity regimen. Eur J Cancer. 2002 Jun;38(9):1204-11. doi: 10.1016/s0959-8049(02)00005-9.

  PMID: 12044507 BACKGROUND

• Cascinu S, Graziano F, Ferrau F, Catalano V, Massacesi C, Santini D, Silva RR, Barni S, Zaniboni A, Battelli N, Siena S, Giordani P, Mari D, Baldelli AM, Antognoli S, Maisano R, Priolo D, Pessi MA, Tonini G, Rota S, Labianca R. Raltitrexed plus oxaliplatin (TOMOX) as first-line chemotherapy for metastatic colorectal cancer. A phase II study of the Italian Group for the Study of Gastrointestinal Tract Carcinomas (GISCAD). Ann Oncol. 2002 May;13(5):716-20. doi: 10.1093/annonc/mdf091.

  PMID: 12075739 BACKGROUND

• Cortinovis D, Bajetta E, Di Bartolomeo M, Dognini G, Beretta E, Ferrario E, Ricotta R, Buzzoni R. Raltitrexed plus oxaliplatin in the treatment of metastatic colorectal cancer. Tumori. 2004 Mar-Apr;90(2):186-91. doi: 10.1177/030089160409000205.

  PMID: 15237580 BACKGROUND

• Laudani A, Gebbia V, Leonardi V, Savio G, Borsellino N, Cusimano MP, Calabria C, Stefano R, Agostara B. Activity and toxicity of oxaliplatin plus raltitrexed in 5-fluorouracil refractory metastatic colorectal adeno-carcinoma. Anticancer Res. 2004 Mar-Apr;24(2C):1139-42.

  PMID: 15154638 BACKGROUND

• Santini D, Massacesi C, D'Angelillo RM, Marcucci F, Campisi C, Vincenzi B, Pilone A, Bianco V, Bonsignori M, Tonini G. Raltitrexed plus weekly oxaliplatin as first-line chemotherapy in metastatic colorectal cancer: a multicenter non-randomized phase ii study. Med Oncol. 2004;21(1):59-66. doi: 10.1385/MO:21:1:59.

  PMID: 15034215 BACKGROUND

• Martoni A, Mini E, Pinto C, Gentile AL, Nobili S, Dentico P, Marino A, Scicolone S, Angelelli B, Mazzei T. Oxaliplatin plus raltitrexed in the treatment of patients with advanced colorectal cancer: a phase II study. Anticancer Res. 2003 Jan-Feb;23(1B):687-91.

  PMID: 12680168 BACKGROUND

• Neri B, Doni L, Fulignati C, Perfetto F, Turrini M, Andreoli F, Pantalone D, Pernice LM, Taruffi F, Martini V, Poma A, Valeri A, Bacci G, Sancez L, Moretti R. Raltitrexed plus oxaliplatin as first-line chemotherapy in metastatic colorectal carcinoma: a multicentric phase II trial. Anticancer Drugs. 2002 Aug;13(7):719-24. doi: 10.1097/00001813-200208000-00006.

  PMID: 12187328 BACKGROUND

• Scheithauer W, Kornek GV, Schuell B, Ulrich-Pur H, Penz M, Raderer M, Lang F, Schneeweiss B, Lenauer A, Depisch D. Second-line treatment with oxaliplatin + raltitrexed in patients with advanced colorectal cancer failing fluoropyrimidine/leucovorin-based chemotherapy. Ann Oncol. 2001 May;12(5):709-14. doi: 10.1023/a:1011194712661.

  PMID: 11432632 BACKGROUND

• Gravalos C, Salut A, Garcia-Giron C, Garcia-Carbonero R, Leon AI, Sevilla I, Maurel J, Esteban B, Garcia-Rico E, Murias A, Cortes-Funes H. A randomized phase II study to compare oxaliplatin plus 5-fluorouracil and leucovorin (FOLFOX4) versus oxaliplatin plus raltitrexed (TOMOX) as first-line chemotherapy for advanced colorectal cancer. Clin Transl Oncol. 2012 Aug;14(8):606-12. doi: 10.1007/s12094-012-0843-x. Epub 2012 Jul 19.

  PMID: 22855138 BACKGROUND

• Feliu J, Castanon C, Salud A, Mel JR, Escudero P, Pelegrin A, Lopez-Gomez L, Ruiz M, Gonzalez E, Juarez F, Lizon J, Castro J, Gonzalez-Baron M; Oncopaz Cooperative Group, Spain. Phase II randomised trial of raltitrexed-oxaliplatin vs raltitrexed-irinotecan as first-line treatment in advanced colorectal cancer. Br J Cancer. 2005 Nov 28;93(11):1230-5. doi: 10.1038/sj.bjc.6602860.

  PMID: 16265344 BACKGROUND

• Cheng K, Chen Y, Li LH, Liu JY. Raltitrexed combined with bevacizumab in heavily pretreated metastatic colorectal cancer. J Cancer Res Ther. 2013 Oct-Dec;9(4):727-9. doi: 10.4103/0973-1482.126470.

  PMID: 24518728 BACKGROUND

• Ito Y, Osaki Y, Tokudome N, Sugihara T, Takahashi S, Iwase T, Hatake K. Efficacy of S-1 in heavily pretreated patients with metastatic breast cancer: cross-resistance to capecitabine. Breast Cancer. 2009;16(2):126-31. doi: 10.1007/s12282-008-0073-9. Epub 2008 Sep 20.

  PMID: 18807123 BACKGROUND

• Hoff PM, Pazdur R, Lassere Y, Carter S, Samid D, Polito D, Abbruzzese JL. Phase II study of capecitabine in patients with fluorouracil-resistant metastatic colorectal carcinoma. J Clin Oncol. 2004 Jun 1;22(11):2078-83. doi: 10.1200/JCO.2004.05.072.

  PMID: 15169794 BACKGROUND

• Sato A, Kurihara M, Horikoshi N, Aiba K, Kikkawa N, Shirouzu K, Mitachi Y, Sakata Y, Wakui A. Phase II study of raltitrexed (Tomudex) in chemotherapy-pretreated patients with advanced colorectal cancer. Tomudex Cooperative Study Group. Anticancer Drugs. 1999 Sep;10(8):741-8. doi: 10.1097/00001813-199909000-00008.

  PMID: 10573207 BACKGROUND

• Douillard JY, Siena S, Cassidy J, Tabernero J, Burkes R, Barugel M, Humblet Y, Bodoky G, Cunningham D, Jassem J, Rivera F, Kocakova I, Ruff P, Blasinska-Morawiec M, Smakal M, Canon JL, Rother M, Oliner KS, Tian Y, Xu F, Sidhu R. Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer. Ann Oncol. 2014 Jul;25(7):1346-1355. doi: 10.1093/annonc/mdu141. Epub 2014 Apr 8.

  PMID: 24718886 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

raltitrexed; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ruilian Xu, MD

  Shen Zhen People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruilian Xu, MD

CONTACT

+8675522942497; xuruilian@126.com

Wan He, MD,phD

CONTACT

+8675522942411; hewanshenzhen@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phase Ⅱ Clinical Study of RALOX or CAPOX Combined With Bevacizumab in the First-line Treatment of Advanced Colorectal Cancer

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: January 23, 2019
• Study Start: January 28, 2019
• Primary Completion: February 28, 2021
• Study Completion: December 31, 2021
• Last Updated: September 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)