The Aim of This Study is to Assess the Efficacy and Safety of Chidamide, Regorafenib in Combination With Iparomlimab and Tuvonralimab for the Treatment of Advanced Colorectal Cancer in Third-line Therapy and Subsequent Lines.

April 8, 2025 updated by: Shanghai Changzheng Hospital

An Exploratory Study Investigating the Combination of Chidamide, Regorafenib, Plus Iparomlimab and Tuvonralimab for the Treatment of Drug-esistant and Efractory Dvanced Colorectal Cancer

Patients with advanced colorectal cancer, particularly those of the pMMR/MSS type, exhibit suboptimal therapeutic responses in the third-line and subsequent treatments. The efficacy of the existing standard treatment regimens is highly restricted. In the CORRECT study, the median overall survival (OS) of regorafenib was 6.4 months, the median progression-free survival (PFS) was 1.9 months, and the objective response rate (ORR) was 1%. In the CONCUR study targeting the Asian population, the median OS of the regorafenib group was 8.8 months, the median PFS was 3.2 months, and the ORR was 4%. In the FRESCO study, the median OS of fruquintinib was 9.3 months, the median PFS was 3.7 months, and the ORR was 4.7%. In the TERRA study, the median OS of trifluridine/tipiracil (TAS-102) was 7.8 months, the median PFS was 2.0 months, and the ORR was 1.1%. The SUNLIGHT study explored the combined treatment modality of TAS-102 plus bevacizumab, where the median OS of the combined regimen was 10.8 months, the median PFS was 5.6 months, and the ORR was 6.1%. Evidently, the therapeutic efficacy of advanced colorectal cancer in the third-line and beyond has plateaued. In recent years, fundamental research has discovered that epigenetic regulation significantly synergizes with anti-angiogenesis and immune checkpoint inhibition therapy. Small-scale clinical explorations have also indicated favorable efficacy and clinical prospects, warranting further investigation. Hence, we contemplate employing the combination of chidamide, regorafenib, and iparomlimab/tuvonralimab to investigate its efficacy and safety in the treatment of advanced colorectal cancer in the third-line and beyond, and to explore novel breakthroughs for refractory colorectal cancer after multiple lines of treatment.

The aim of this study is to assess the efficacy and safety of the combination regimen of chidamide, regorafenib, and iparomlimab/tuvonralimab in patients with advanced colorectal cancer in the third-line and beyond. The study will be conducted at Shanghai Changzheng Hospital. The study drugs, including chidamide, regorafenib, and iparomlimab/tuvonralimab, are all commercially available in China.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200003
        • Recruiting
        • Department of Medical Oncology, Second Affiliated Hospital of Naval Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with advanced colorectal adenocarcinoma confirmed by histology or cytology;
  • Those who have experienced disease progression or are intolerant to treatment after receiving ≥ 2 lines of systemic standard therapy;
  • Patients must have at least one measurable lesion (according to RECIST 1.1 criteria);
  • Patients who have received local radiotherapy at least 3 weeks before the first drug treatment are eligible for inclusion; however, the lesions evaluated by RECIST must not be within the radiotherapy field;
  • Patients must be at least 18 years old;
  • Performance status ECOG score of 0-1;
  • Expected survival ≥ 12 weeks;
  • Patients must have the ability to understand and voluntarily sign the written informed consent form;
  • Women of childbearing age must have a negative pregnancy test within 7 days before the start of treatment. During the study period, both the patient and the patient's spouse must take contraceptive measures.

Exclusion Criteria:

  • Patients who have undergone major surgery or suffered severe trauma within 4 weeks prior to the first dose of the study drug;
  • Patients with hypersensitivity to any component of the study protocol;
  • Patients planning to conceive or who are pregnant;
  • Patients with brain metastases and an inability to accurately describe their condition;
  • Patients who have experienced any of the following diseases within 6 months prior to the start of the study treatment: myocardial infarction, severe/unstable angina pectoris, NYHA class 2 or higher congestive heart failure, uncontrolled arrhythmia, etc.;
  • Abnormal laboratory tests:

Absolute neutrophil count (ANC) < 1,500/mm3; Platelet count < 75,000/mm3; Total bilirubin > 1.5 times the upper limit of normal; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (for patients with liver metastases > 5 times the upper limit of normal); Creatinine > 1.5 times the upper limit of normal;

  • Patients who have had other cancers (except advanced colorectal cancer) within 5 years prior to the start of this study treatment. Cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumors are excluded;
  • Patients with a history of drug abuse, drug addiction, or alcohol dependence;
  • Patients without legal capacity or with limited civil capacity;
  • Other conditions that the investigator deems inappropriate for inclusion in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the combination regimen of chidamide, regorafenib, and iparomlimab/tuvonralimab
Drug: chidamide, regorafenib, and iparomlimab/tuvonralimab
All patients were treated with the following regimen: Chidamide: 30mg per dose, twice a week; Regorafenib: 80mg per dose, once a day, orally for 3 weeks, followed by a 1-week rest, and repeated every 4 weeks; Iparomlimab/Tuvonralimab: 5mg/kg, once every 3 weeks, intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate, ORR
Time Frame: From enrollment to the end of treatment at 8 weeks
CR+PR
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changzheng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 10, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Apical-vict

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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