Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer

NCT ID: NCT06011330

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-02-10

Brief Summary

The survival of the refractory CRC is dismal and therapy options are limited ，the researchers aim to investigate the efficacy, safety, and predictors of fruquintinib plus PD-1 in refractory MSS metastatic colorectal cancer in a real-world setting.

Detailed Description

The invesgators conducted a retrospective single arm, single-center study in which patients with MSS/pMMR mCRC were received fruquintinib combined with anti-PD-1 antibodies after progressed at least two lines of standard chemotherapy with or without targeted drugs such as bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June 2022. Eligible patients were aged 18 years or older and had histologically or cytologically confirmed adenocarcinoma of the colon or rectum; with patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1).The primary endpoint was overall survival (OS).

Conditions

Colorectal Cancer

Study Design

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

Study Groups

study group

fruquintinib combined with anti-PD-1 antibodies

Fruquintinib combined with anti-PD-1 antibodies

Intervention Type: DRUG

Fruquintinib (3-5mg once daily for 21 days on/7 days off) anti-PD-1 antibodies (including sintilimab, toripalimab, pembrolizumab, tislelizumab, and nivolumab).

Interventions

Fruquintinib combined with anti-PD-1 antibodies

Fruquintinib (3-5mg once daily for 21 days on/7 days off) anti-PD-1 antibodies (including sintilimab, toripalimab, pembrolizumab, tislelizumab, and nivolumab).

Intervention Type: DRUG

Other Intervention Names

programmed cell death protein 1; immune checkpoint inhibitor

Eligibility Criteria

Inclusion Criteria

1. patients with MSS/pMMR mCRC who have been received Fruquintinib combined with anti-PD-1 antibodies after progressed at least two lines of standard chemotherapy with or without targeted drugs such as bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June 2022;

2. Eligible patients were aged 18 years or older

3. had histologically or cytologically confirmed adenocarcinoma of the colon or rectum;

4. patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1).

5. an Eastern Cooperative Oncology Group performance status of 0-2;

Exclusion Criteria

1. Pregnancy, lactating female or possibility of becoming pregnant during the study.

2. Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation).

3. Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.

4. Has severe or uncontrolled active acute or chronic infection. 5.Known carriers of HIV antibodies. 6.Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.

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

Sponsors

Hunan Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hunan Cancer Hospital

Changsha, Hunan, China

Countries

China

Other Identifiers

FRUPD-1

Identifier Type: -

Identifier Source: org_study_id