Fruquintinib in the Cross-line Treatment of Refractory mCRC

Recruiting

• Conditions: Fruquintinib; Metastatic Colorectal Cancer
• Interventions: Drug: Fruquintinib+PD-1 inhibitors; Drug: Fruquintinib+TAS-102

• Registration Number: NCT06099314
• Lead Sponsor: Wuhan Union Hospital, China

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.

Detailed Description

This is a real-world study. 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. The primary endpoint was observation the overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102. The study objective is to explore the possibility of cross-line rechallenge of fruquinitinib.

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Study First Posted: 2023-10-25
• Last Update Posted: 2023-10-25
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

To be enrolled in this study, patients must meet all of the following criteria:

1. Age ≥18 years, ≤75 years;
2. No gender limitation;
3. 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.
4. Expected survival ≥12 weeks
5. Must have at least one measurable lesion (RECIST1.1).
6. Full organ and bone marrow function.

Exclusion Criteria

Patients will not be admitted to the study if they meet any of the following criteria:

1. Patients with contraindications to study drugs (fruquinitinib, PD-1 inhibitor, TAS-102);
2. allergic to the investigational drug or any of its adjuncts;
3. There are other non-investigational drugs during third-line and fourth-line treatment;
4. Pregnant or lactating female subjects;
5. Patients with a large number of pleural effusion or ascites requiring drainage;
6. Patients considered unsuitable for inclusion in this study by the investigators.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fruquintinib Rechallenge	Fruquintinib+PD-1 inhibitors	1. third-line treatment with fruquintinib combined with PD-1 inhibitors 2. fourth-line treatment with fruquintinib combined with TAS-102
Fruquintinib Rechallenge	Fruquintinib+TAS-102	1. third-line treatment with fruquintinib combined with PD-1 inhibitors 2. fourth-line treatment with fruquintinib combined with TAS-102

Primary Outcome Measures

Name	Time	Method
Overall survival 2(OS2)	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	Overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102

Secondary Outcome Measures

Name	Time	Method
Objective response rate 2(ORR2, investigator based on RECIST1.1)	from received fruquinitinib combined with TAS-102 to one year	Objective response rate (ORR) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
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	Progression-free survival (PFS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
Disease control rate 2 (DCR2, investigators based on RECIST1.1)	from received fruquinitinib combined with TAS-102 to one year	Disease control rate (DCR) of fourth-line treatment of mCRC with fruquinitinib and TAS-102

Trial Locations

Locations (3)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

TONGJI Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China