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Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer

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

NCT06011330•Hunan Cancer Hospital

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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).

Eligibility

Age

18 - 75 years

Sex

ALL

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.

Locations (1)

Hunan Cancer Hospital

Changsha, Hunan, China

Key Dates

Start Date

January 1, 2019

Primary Completion Date

June 30, 2022

Completion Date

February 10, 2023

Last Updated

August 30, 2023

Enrollment

ACTUAL participants

Conditions

Colorectal Cancer

Interventions

Fruquintinib combined with anti-PD-1 antibodies

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease