Adjuvant Treatment of Digestive Tract Tumors

NCT05742620 | Not Yet Recruiting

• 1 other identifier: TQXB-GC-II-003
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the 3-year Disease-free survival rate(DFSR) of patients with locally advanced gastric cancer and colorectal cancer treated with anlotinib combined with adjuvant chemotherapy.

Conditions

Adjuvant Treatment

Outcome Measures

Primary Outcomes (1)

• 3y-DFSR

  3-year Disease-free survival

  3years

Secondary Outcomes (2)

• DFS

  3years

• 3y-OSR

  3years

Study Arms (1)

anlotinib+CAPEOX/SOX

EXPERIMENTAL

Adjuvant treatment of locally advanced gastric cancer and colorectal cancer

Drug: anlotinib+CAPEOX/SOX

Interventions

anlotinib+CAPEOX/SOX DRUG

Patients with colorectal cancer use the anlotinib+CAPEOX protocol, and patients with gastric cancer use the anlotinib+SOX protocol. Anlotinib: 12mg, administered once a day on day 1-14, taken about half an hour before breakfast (the time of daily administration should be the same as much as possible), delivered with warm water, repeated once every three weeks; CAPEOX: capecitabine 1000mg/m2 each time, oral, twice a day, 1-14 days; Oxaliplatin: 130mg/m2 iv drip d1. SOX: Tegio: 100mg/day, continuous medication for 2 weeks, stop for 1 week; Oxaliplatin: 130mg/m2 iv drip d1.

Also known as: anlotinib+chemotherapy

anlotinib+CAPEOX/SOX

Eligibility Criteria

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

You may qualify if:

• years old ≤ age ≤ 75 years old, male or female;
• \. ECOG score 0\~2 points;
• \. Patients with locally advanced gastric cancer and colorectal cancer after radical surgery (R0 resection);
• \. Gastric cancer: patients with stage III (pT1N3bM0, pT2N3M0, pT3N2-3M0, pT4aN1-3M0, pT4bN0-3M0);
• \. Colorectal cancer: patients with stage III (T any N+M0);
• \. Normal function of main organs
• \. Female subjects of childbearing age must carry out a serum pregnancy test within 3 days before starting the study medication, and the result is negative, and are willing to use a medically approved effective contraceptive measure (such as intrauterine device, contraceptive or condom) during the study period and within 3 months after the last administration of the study medication; For male subjects whose partners are women of childbearing age, they should undergo surgical sterilization or agree to use effective methods of contraception during the study and within 3 months after the last study administration.
• \. Subjects voluntarily joined the study and signed the informed consent form, with good compliance and cooperation in follow-up.

You may not qualify if:

• \. Postoperative distal metastasis or failure to achieve R0 resection;
• \. Have experienced any anti-tumor treatment before surgery, including chemotherapy, radiotherapy and targeted drug treatment;
• \. Patients with contraindications to chemotherapy;
• \. Other malignant tumors in the past 3 years;
• \. Clinically obvious bleeding symptoms or obvious bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood++or above the baseline, or vasculitis);
• \. Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, despite the best drug treatment);
• \. People newly diagnosed with angina pectoris within 3 months before screening or suffering from serious cardiovascular diseases within 6 months before screening, including unstable angina pectoris or myocardial infarction; Arrhythmias (including QTcF: male ≥ 450 ms, female ≥ 470 ms) require long-term use of antiarrhythmic drugs; ≥ Grade 2 congestive heart failure (NYHA classification);
• \. Severe infection (such as the need for intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever of unknown cause occurred during screening/before the first administration\>38.5 ° C;
• \. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• \. Pregnant or lactating women; Those with fertility who are unwilling or unable to take effective contraceptive measures;
• \. It is known that it will produce allergy, hypersensitivity or intolerance to the test drug and its excipients;
• \. Subjects who are participating in other clinical studies or whose first medication is less than 4 weeks from the end of the previous clinical study (the last medication), or who have 5 half-lives of the study drug;
• \. Subjects are known to have a history of abuse of psychotropic substances, alcohol or drug abuse;
• \. The researcher believes that there are any conditions that may harm the subject or cause the subject to fail to meet or perform the research requirements.

Sponsors & Collaborators

• Xijing Hospital: lead

Related Publications (5)

• Grothey A, Sobrero AF, Shields AF, Yoshino T, Paul J, Taieb J, Souglakos J, Shi Q, Kerr R, Labianca R, Meyerhardt JA, Vernerey D, Yamanaka T, Boukovinas I, Meyers JP, Renfro LA, Niedzwiecki D, Watanabe T, Torri V, Saunders M, Sargent DJ, Andre T, Iveson T. Duration of Adjuvant Chemotherapy for Stage III Colon Cancer. N Engl J Med. 2018 Mar 29;378(13):1177-1188. doi: 10.1056/NEJMoa1713709.

  PMID: 29590544 BACKGROUND

• Andre T, Meyerhardt J, Iveson T, Sobrero A, Yoshino T, Souglakos I, Grothey A, Niedzwiecki D, Saunders M, Labianca R, Yamanaka T, Boukovinas I, Vernerey D, Meyers J, Harkin A, Torri V, Oki E, Georgoulias V, Taieb J, Shields A, Shi Q. Effect of duration of adjuvant chemotherapy for patients with stage III colon cancer (IDEA collaboration): final results from a prospective, pooled analysis of six randomised, phase 3 trials. Lancet Oncol. 2020 Dec;21(12):1620-1629. doi: 10.1016/S1470-2045(20)30527-1.

  PMID: 33271092 BACKGROUND

• Petrelli F, Labianca R, Zaniboni A, Lonardi S, Galli F, Rulli E, Rosati G, Corallo S, Ronzoni M, Cardellino GG, Mattioli R, Mambrini A, Ciuffreda L, Banzi M, Pusceddu V, Maiello E, Zampino M, Zagonel V, Marchetti P, Corsi D, Rimassa L, Cinieri S, Sobrero A. Assessment of Duration and Effects of 3 vs 6 Months of Adjuvant Chemotherapy in High-Risk Stage II Colorectal Cancer: A Subgroup Analysis of the TOSCA Randomized Clinical Trial. JAMA Oncol. 2020 Apr 1;6(4):547-551. doi: 10.1001/jamaoncol.2019.6486.

  PMID: 32053133 BACKGROUND

• Iveson TJ, Sobrero AF, Yoshino T, Souglakos I, Ou FS, Meyers JP, Shi Q, Grothey A, Saunders MP, Labianca R, Yamanaka T, Boukovinas I, Hollander NH, Galli F, Yamazaki K, Georgoulias V, Kerr R, Oki E, Lonardi S, Harkin A, Rosati G, Paul J. Duration of Adjuvant Doublet Chemotherapy (3 or 6 months) in Patients With High-Risk Stage II Colorectal Cancer. J Clin Oncol. 2021 Feb 20;39(6):631-641. doi: 10.1200/JCO.20.01330. Epub 2021 Jan 13.

  PMID: 33439695 BACKGROUND

• Tanabe K, Fujii M, Nishikawa K, Kunisaki C, Tsuji A, Matsuhashi N, Takagane A, Ohno T, Kawase T, Kochi M, Yoshida K, Kakeji Y, Ichikawa W, Chin K, Terashima M, Takeuchi M, Nakajima T. Phase II/III study of second-line chemotherapy comparing irinotecan-alone with S-1 plus irinotecan in advanced gastric cancer refractory to first-line treatment with S-1 (JACCRO GC-05). Ann Oncol. 2015 Sep;26(9):1916-1922. doi: 10.1093/annonc/mdv265. Epub 2015 Jun 24.

  PMID: 26109630 BACKGROUND

Study Officials

• DeLiang Yu, Doctor

  Ambulatory Surgery Center

  STUDY CHAIR

Central Study Contacts

DeLiang Yu, Doctor

CONTACT

0086-15339290897; ydl0915@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: February 24, 2023
• Study Start: June 20, 2023
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 20, 2029
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share