Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer

NCT06011330 | Completed

• 1 other identifier: FRUPD-1
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Fruquintinib; PD-1; pMMR/MSS

Outcome Measures

Primary Outcomes (1)

• overall survival (OS)

  Overall survival defined as the observed time from the treatment of the study until death due to any cause

  assessed up to 2 year

Secondary Outcomes (1)

• progress-free survival (PFS)

  assessed up to 1 year

Other Outcomes (3)

• objective response rate (ORR)

  assessed up to 1 year

• disease control rate (DCR)

  assessed up to 1 year

• Treatment-Related Adverse Events (TRAE)

  assessed up to 1 year

Study Arms (1)

study group

fruquintinib combined with anti-PD-1 antibodies

Drug: Fruquintinib combined with anti-PD-1 antibodies

Interventions

Fruquintinib combined with anti-PD-1 antibodies DRUG

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

Also known as: programmed cell death protein 1, immune checkpoint inhibitor

study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Refractory MSS Metastatic Colorectal Cancer

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Programmed Cell Death 1 Receptor; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Immune Checkpoint Proteins; Proteins; Amino Acids, Peptides, and Proteins; Costimulatory and Inhibitory T-Cell Receptors; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antigens, Differentiation, T-Lymphocyte; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Biomarkers; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: January 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: February 10, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)