Fruquintinib and Raltitrexed Versus Fruquintinib Monotherapy in Advanced Colorectal Cancer

NCT04582981 | Unknown Phase 2

• 1 other identifier: FDZL-FRaF
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, controlled phase II clinical trial of Fruquintinib combined with Raltitrexed versus Fruquintinib monotherapy in patients with advanced colorectal cancer who had failed second-line or above standard chemotherapy

Conditions

Advanced Colorectal Carcinoma

Keywords

advanced colorectal cancer; fruquintinib; raltitrexed; target therapy

Outcome Measures

Primary Outcomes (1)

• progression free survival (PFS)

  the time from randomization to tumor progression or death from any cause,whichever came first

  assessed up to 24 months

Secondary Outcomes (3)

• overall survival (OS)

  assessed up to 36 months

• objective response rate (ORR)

  through study completion, an average of 2 year

• disease control rate (DCR)

  through study completion, an average of 2 year

Other Outcomes (1)

• quality of life score (QOL)

  through study completion, an average of 2 year

Study Arms (2)

Arm A

EXPERIMENTAL

Combination treatment of Fruquintinib and Raltitrexed

Drug: Fruquintinib and raltitrexed

Arm B

EXPERIMENTAL

Monotherapy of Fruquintinib

Drug: Fruquintinib

Interventions

Fruquintinib and raltitrexed DRUG

Fruquintinib 5mg qd plus raltitrexed 2mg/m2, q2w

Also known as: F and R

Arm A

Fruquintinib DRUG

Fruquintinib 5mg qd monotherapy

Also known as: F

Arm B

Eligibility Criteria

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

You may qualify if:

• no less than 18 years old
• confirmed by histopathological examination, recurrent/metastatic colorectal adenocarcinoma
• had received at least two lines standard chemotherapy and failed. These standard regimens must include fluorouracil, oxaliplatin, and irinotecan. Treatment failure was defined as disease progression within 3 months after the last treatment or intolerance of toxicity or side effects during treatment ; Note: A. each line of treatment shall include more than one cycle of chemotherapeutic agents; B. adjuvant/neoadjuvant therapy is allowed in the former treatment. If recurrence or metastasis occurs during adjuvant/neoadjuvant therapy or within 6 months after completion, adjuvant/neoadjuvant therapy is considered a failure of first-line chemotherapy for the advanced disease; C. Prior antitumor therapy regimens using chemotherapy combined with cetuximab or bevacizumab were permitted.
• with one or more measurable lesions, according to RECIST criteria, version 1.1;
• Eastern Cooperative Oncology Group (ECOG) performance score(PS) from 0 to 2;
• Life expectancy no less than 12 weeks;
• Acceptable hematologic, hepatic, and renal function within 7 days from screening： the blood neutrophil count≥1.5x109 /L; hemoglobin ≥ 9.0 g/dl，the blood platelet count≥80 x109 /L, total bilirubin \< 1.5 x upper normal limit（UNL), alanine aminotransferase（ALT） and aspartate transaminase（AST）\< 2.5 x UNL(\< 5 x UNL for patients with live metastasis), serum creatinine≤1 x UNL，endogenous creatinine clearance rate \>50ml/min
• Women of reproductive age need to take effective contraceptive measures.
• Participate in this study voluntarily and sign informed consent. Understand the purpose of this study and the necessary procedures. Good compliance to cooperate with the follow-up.

You may not qualify if:

• urine protein 2 + or above, or 24 hours urinary protein quantitative acuity 1.0 g / 24 h
• Abnormal coagulation function or those receiving thrombolytics or anticoagulants
• Patients with tendency of gastrointestinal hemorrhage, including active peptic ulcer with fecal occult blood ++, hematemesis or melena within 3 months
• Received other systemic anti-tumor therapy, including cell signal transduction inhibitors, drug therapy, immune therapy within 3 weeks
• With uncontrolled high blood pressure (systolic blood pressure \> 140 MMHG, diastolic blood pressure \> 90 MMHG)
• Radiotherapy therapy for target lesions
• symptomatic cerebral or meningeal metastasis;
• Uncontrolled pleural or peritoneal effusion
• Undergoing dialysis
• Severe or uncontrolled infection
• With multiple factors that affecting oral administration
• Former exposed to any VEGFR tyrosine kinase inhibitors (e.g regorafenib, apatinib, anlotinib etc.) for treatment
• Raltitrexed treatment for more than one cycle in former line therapy

Sponsors & Collaborators

• Fudan University: lead
• Shanxi Province Cancer Hospital: collaborator

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (3)

• Li J, Qin S, Xu RH, Shen L, Xu J, Bai Y, Yang L, Deng Y, Chen ZD, Zhong H, Pan H, Guo W, Shu Y, Yuan Y, Zhou J, Xu N, Liu T, Ma D, Wu C, Cheng Y, Chen D, Li W, Sun S, Yu Z, Cao P, Chen H, Wang J, Wang S, Wang H, Fan S, Hua Y, Su W. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018 Jun 26;319(24):2486-2496. doi: 10.1001/jama.2018.7855.

  PMID: 29946728 RESULT

• Pfeiffer P, Yilmaz M, Moller S, Zitnjak D, Krogh M, Petersen LN, Poulsen LO, Winther SB, Thomsen KG, Qvortrup C. TAS-102 with or without bevacizumab in patients with chemorefractory metastatic colorectal cancer: an investigator-initiated, open-label, randomised, phase 2 trial. Lancet Oncol. 2020 Mar;21(3):412-420. doi: 10.1016/S1470-2045(19)30827-7. Epub 2020 Jan 27.

  PMID: 31999946 RESULT

• Cunningham D, Zalcberg JR, Rath U, Oliver I, van Cutsem E, Svensson C, Seitz JF, Harper P, Kerr D, Perez-Manga G. Final results of a randomised trial comparing 'Tomudex' (raltitrexed) with 5-fluorouracil plus leucovorin in advanced colorectal cancer. "Tomudex" Colorectal Cancer Study Group. Ann Oncol. 1996 Nov;7(9):961-5. doi: 10.1093/oxfordjournals.annonc.a010800. No abstract available.

  PMID: 9006748 RESULT

MeSH Terms

Interventions

HMPL-013; raltitrexed

Study Officials

• Weijian Guo

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenchen Wang

CONTACT

+862164433755; wccnancy2003@aliyun.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: Professor

Model Details: This study is an open-label, randomized, controlled, multi-centered phase II clinical trial

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: October 12, 2020
• Study Start: September 28, 2020
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)