Fruquintinib in the Cross-line Treatment of Refractory mCRC

NCT ID: NCT06099314

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2025-09-30

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.

Conditions

Fruquintinib; Metastatic Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Fruquintinib Rechallenge

1. third-line treatment with fruquintinib combined with PD-1 inhibitors

2. fourth-line treatment with fruquintinib combined with TAS-102

Fruquintinib+PD-1 inhibitors

Intervention Type: 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+TAS-102

Intervention Type: 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.

Interventions

Fruquintinib+PD-1 inhibitors

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.

Intervention Type: DRUG

Fruquintinib+TAS-102

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Zhenyu Lin

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhenyu Lin

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Wuhan, Hubei, China

Site Status: RECRUITING

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

Wuhan, Hubei, China

Site Status: RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhenyu Lin

Role: CONTACT

whxhlzy@hust.edu.cn

15827130393

Facility Contacts

Dongbo Liu

Role: primary

ZhenYu Lin

Role: primary

wenbo wang

Role: primary

Other Identifiers

HMPL-013-C2-CRC05

Identifier Type: -

Identifier Source: org_study_id