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

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

This study is testing a new combination of four drugs to see if it can help people with advanced colorectal cancer who haven't had success with other treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Changzheng Hospital (other)
• Drugs / interventions: bevacizumab, iparomlimab, tuvonralimab, fruquintinib
• Locations: 1 site (Shanghai)
• Trial ID: NCT06930118 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced colorectal adenocarcinoma who have progressed after at least two lines of systemic therapy.

Not a fit: Patients who have not received prior systemic therapy or those with non-advanced colorectal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival outcomes for patients with advanced colorectal cancer who have limited options.

How similar studies have performed: While previous studies have shown limited success with existing treatments for advanced colorectal cancer, this combination approach is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Shanghai

• Department of Medical Oncology, Second Affiliated Hospital of Naval Medical University — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Zhan Wang

Conditions: Advanced Colorectal Cancer in the Third-line Treatment and Beyond, pMMR/MSS Advanced Colorectal Cancer, advanced colorectal cancer