Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer

Sponsor

Hunan Cancer Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06011330

Collaborator

(none)

Enrollment

Location

49.3

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: Fruquintinib combined with anti-PD-1 antibodies

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 Design

Study Type:

Observational

Actual Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Efficacy , Safety, and Predictors of Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer in a Real-world Setting

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jun 30, 2022

Actual Study Completion Date :

Feb 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
study group fruquintinib combined with anti-PD-1 antibodies	Drug: 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). Other Names: programmed cell death protein 1 immune checkpoint inhibitor

Arm

Intervention/Treatment

study group

fruquintinib combined with anti-PD-1 antibodies

Drug: 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).

Other Names:

programmed cell death protein 1

immune checkpoint inhibitor

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

objective response rate (ORR) [assessed up to 1 year]
The ORR was calculated as the sum of the proportion of complete responses (CRs) and partial responses (PRs) according to RECIST version 1.1 criteria and using investigator's tumor assessment
disease control rate (DCR) [assessed up to 1 year]
Disease control rate has been defined as the addition of (CR + PR) rate and also stable disease (SD) rate, according to RECIST v 1.1
Treatment-Related Adverse Events (TRAE) [assessed up to 1 year]
Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAEs)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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;
Eligible patients were aged 18 years or older
had histologically or cytologically confirmed adenocarcinoma of the colon or rectum;
patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1).
an Eastern Cooperative Oncology Group performance status of 0-2;

Exclusion Criteria:

Pregnancy, lactating female or possibility of becoming pregnant during the study.
Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation).
Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
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.