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

Hunan Cancer Hospital (Other)
Overall Status
Completed ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: regorafenib plus anti-PD-1 antibodies

Detailed Description

We retrospectively analyzed the efficacy and safety of 103 pMMR/MSS mCRC patients treated with at least one dose of anti-PD-1 antibodies plus regorafenib (80 mg once daily for 21 days on/7 days off 28 days as a cycle) between July 2019 and June 2021 at the Hunan Cancer Hospital. All patients had previously received at least second-line treatment. The patients were evaluated by computed tomography every 2 or 3 treatment cycles until progression or being lost to follow-up. The primary end point was overall survival (OS).

Study Design

Study Type:
Actual Enrollment :
103 participants
Observational Model:
Time Perspective:
Official Title:
Efficacy and Safety of Anti-PD-1 Antibody Plus Regorafenib in Refractory Microsatellite Stable Metastatic Colorectal Cancer: a Retrospective Single-arm Cohort Study
Actual Study Start Date :
Jul 1, 2019
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Sep 30, 2021

Outcome Measures

Primary Outcome Measures

  1. Overall Survival (OS) [Approximately 12 months]

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

Secondary Outcome Measures

  1. Progression-free survival (PFS) [Approximately 12 months]

    Progression-free survival defined as the time elapsed between the date of commencement of treatment and the date of radiologic tumour progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.

  2. Overall response rate (ORR) [Approximately 12 months]

    Overall response rate (ORR) was regarded as the proportion of complete responses (CRs) and partial responses (PRs) according to RECIST version 1.1 criteria and using investigator's tumor assessment

  3. Disease control rate (DCR) [Approximately 12 months]

    Disease control rate has been defined as the addition of (CR + PR) rate and also stable disease (SD) rate

  4. Treatment-Related Adverse Events (TRAE) [Approximately 12 months]

    Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAEs)

Eligibility Criteria


Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Inclusion Criteria:

  • 1.Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded).

  1. 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).

3.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.

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.

Contacts and Locations


Site City State Country Postal Code
1 Hunan Cancer hospital Changsha Hunan China

Sponsors and Collaborators

  • Hunan Cancer Hospital


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Hunan Cancer Hospital Identifier:
Other Study ID Numbers:
  • REGOPD-1-Hunan
First Posted:
Jul 12, 2023
Last Update Posted:
Jul 12, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Hunan Cancer Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2023