Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer

Central South University

Status: Completed

Conditions: Colorectal Cancer

Treatments: Drug: Fruquintinib combined with anti-PD-1 antibodies

Study type: Observational

Funder types: Other

Identifiers

NCT06011330

FRUPD-1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

70 participants in 1 patient group

study group

Description:

fruquintinib combined with anti-PD-1 antibodies

Treatment:

Drug: Fruquintinib combined with anti-PD-1 antibodies