Fruquintinib in the Cross-line Treatment of Refractory mCRC

NCT06099314 | Unknown

• 1 other identifier: HMPL-013-C2-CRC05
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

This is a real-world study. Patients with metastatic colorectal cancer who have progressed (PD) after third-line treatment with fruquintinib combined with PD-1 inhibitors will receive fruquintinib combined with TAS-102 as fourth-line therapy. The objective of this study was to observe the efficacy and safety of cross-line（from third to fourth line）treatment with fruquinitinib.

Conditions

Fruquintinib; Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival 2(OS2)

  Overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102

  From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented date of death from any cause , assessed up to 12 months

Secondary Outcomes (3)

• Objective response rate 2(ORR2, investigator based on RECIST1.1)

  from received fruquinitinib combined with TAS-102 to one year

• Progression-free survival 2(PFS2, investigators based on RECIST1.1)

  From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

• Disease control rate 2 (DCR2, investigators based on RECIST1.1)

  from received fruquinitinib combined with TAS-102 to one year

Study Arms (1)

Fruquintinib Rechallenge

1. third-line treatment with fruquintinib combined with PD-1 inhibitors 2. fourth-line treatment with fruquintinib combined with TAS-102

Drug: Fruquintinib+PD-1 inhibitors; Drug: Fruquintinib+TAS-102

Interventions

Fruquintinib+PD-1 inhibitors DRUG

Third-line treatment with fruquintinib combined with PD-1 inhibitors. Fruquintinib: 5mg,Oral once daily,2 weeks on/1 week off,Q3W； PD-1 inhibitor：for example, Sintilimab,iv,200mg, Q3W.

Fruquintinib Rechallenge

Fruquintinib+TAS-102 DRUG

Fourth-line treatment with fruquintinib combined with TAS-102 . Fruquintinib: 3-5mg(Depending on the patient's physical condition), Oral once daily,3 weeks on/1 week off,Q4W； TAS-102:orally, 35mg/m2 twice daily (maximum dose 80mg in a single dose) for days 1-5, repeated every 14 days.

Fruquintinib Rechallenge

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic colorectal cancer

You may qualify if:

• To be enrolled in this study, patients must meet all of the following criteria:
• Age ≥18 years, ≤75 years;
• No gender limitation;
• Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received.
• Expected survival ≥12 weeks
• Must have at least one measurable lesion (RECIST1.1).
• Full organ and bone marrow function.

You may not qualify if:

• Patients will not be admitted to the study if they meet any of the following criteria:
• Patients with contraindications to study drugs (fruquinitinib, PD-1 inhibitor, TAS-102);
• allergic to the investigational drug or any of its adjuncts;
• There are other non-investigational drugs during third-line and fourth-line treatment;
• Pregnant or lactating female subjects;
• Patients with a large number of pleural effusion or ascites requiring drainage;

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (3)

TONGJI Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• Zhenyu Lin

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenyu Lin

CONTACT

15827130393; whxhlzy@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 25, 2023
• Study Start: October 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

CN (3)