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Tests treatment safety and results for Advanced Colorectal Cancer in the Third-line Treatment...
Official title 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.
ClinicalTrials.gov ID: NCT06930118
What this study is testing
What is chidamide, regorafenib, and iparomlimab/tuvonralimab?
chidamide, regorafenib, and iparomlimab/tuvonralimab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced colorectal cancer in the third-line treatment and beyond.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients must be at least 18 years old;
You likely can't join if
- 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...
- Abnormal laboratory tests: Absolute neutrophil count (ANC) \ 1.5 times the upper limit of normal; Alanine aminotransferase (ALT) and aspartate...
See the full eligibility 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.
- 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...
- Abnormal laboratory tests: Absolute neutrophil count (ANC) \ 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.