Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Fruquintinib combined with anti-PD-1 antibodies

• Registration Number: NCT06011330
• Lead Sponsor: Hunan Cancer Hospital

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).

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2023-02-10
• Status Verified: 2023-08
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-25
• Last Update Submitted: 2023-08-27
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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;

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	Fruquintinib combined with anti-PD-1 antibodies	fruquintinib combined with anti-PD-1 antibodies

Primary Outcome Measures

Name	Time	Method
overall survival (OS)	assessed up to 2 year	Overall survival defined as the observed time from the treatment of the study until death due to any cause

Secondary Outcome Measures

Name	Time	Method
progress-free survival (PFS)	assessed up to 1 year	the time from treatment initiation to the disease progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 ChangSha, Hunan, China