Assessing the effectiveness of a new drug combination for advanced colorectal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of a combination treatment involving chidamide, regorafenib, iparomlimab, and tuvonalimab for patients with advanced colorectal cancer who have not responded to previous therapies. It targets patients with pMMR/MSS advanced colorectal cancer in the third-line treatment and beyond, aiming to improve overall survival and progression-free survival rates. The study will include patients who have experienced disease progression after at least two lines of systemic therapy and have measurable lesions. The approach seeks to address the limitations of existing treatment regimens that have shown suboptimal responses.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Zhan Wang
• Email: 13916229609@139.com
• Phone: 86 21 66540109-8007

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.