Anti-PD-1 Antibody Plus Regorafenib in Refractory Microsatellite Stable Metastatic Colorectal Cancer

NCT05942768 | Completed

• 1 other identifier: REGOPD-1-Hunan
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Managements for refractory proficient mismatch repair (pMMR) or microsatellite stable (MSS) metastatic colorectal cancer (mCRC) were still challenging and controversial. Our study sought to investigate the efficacy and safety of anti-PD-1 antibodies plus regorafenib in refractory pMMR/MSS mCRC between July 2019 and June 2021 at the Hunan Cancer Hospital.

Conditions

Metastatic Colorectal Adenocarcinoma

Keywords

Colorectal cancer;regorafenib;anti-PD-1 antibodies

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival defined as the observed time elapsed between the date of commencement of treatment and the date of death due to any cause

  Approximately 12 months

Secondary Outcomes (4)

• Progression-free survival (PFS)

  Approximately 12 months

• Overall response rate (ORR)

  Approximately 12 months

• Disease control rate (DCR)

  Approximately 12 months

• Treatment-Related Adverse Events (TRAE)

  Approximately 12 months

Interventions

regorafenib plus anti-PD-1 antibodies DRUG

The patients were treated orally with regorafenib (80 mg once daily for 21 days on/7 days off, over a 28-day cycle), combined with 1 of the 5 anti-PD-1 antibodies (i.e., nivolumab, pembrolizumab, camrelizumab, sintilimab, or toripalimab). The anti-PD-1 antibody was administered intravenously on day 1, and its recommended dosage was as follows: nivolumab: 240 mg, every 2 weeks; pembrolizumab, camrelizumab, and sintilimab: 200 mg every 3 weeks; and toripalimab: 240 mg every 3 weeks

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

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

Study population were the patients treated with at least 1 cycle of anti-PD-1 antibodies plus regorafenib between July 2019 and June 2021 at the Hunan Cancer Hospital.

You may qualify if:

• Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded).
• \. Have progressed from at least 2 lines of standard treatment,including fluoropyrimidines, irinotecan, oxaliplatin, with or without targeted drugs, like bevacizumab and cetuximab (only for RAS wild-type).
• Has measurable or non-measurable disease as defined by RECIST version 1.1 4.Is able to swallow oral tablets. 5.Estimated life expectancy ≥12 weeks. 6.Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 7. Has adequate organ function.

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

Interventions

regorafenib; Programmed Cell Death 1 Receptor; Immune Checkpoint Inhibitors

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: July 4, 2023
• First Posted: July 12, 2023
• Study Start: July 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: please contact the principal investigator of this study or correspondence author.

Locations

CN (1)