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New treatment option for CRC
Official title Cadonilimab Combined With Regorafenib as A Third-line Treatment in Patients With MSS CRLM
ClinicalTrials.gov ID: NCT06455254
What this study is testing
What is Candonilimab (AK104)?
Candonilimab (AK104) is an investigational medicine, being studied as a potential treatment for crc.
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
- This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of Candonilimab (AK104) combined with Regorafenib for the treatment of MSS colorectal liver metastasis. Candonilimab (AK104) is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.
- 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 to 75
You may be able to join if
- Age \> 18 years old and \< 75 years old;
- ECOG Performance status score 0 or 1;
- Histologically or cytologically confirmed adenocarcinoma of colon or rectum, with liver metastases, with or without extrahepatic metastases;
- At least one measurable lesion as defined by RECIST version 1.1;
- Progressed or be intolerant to prior systemic therapy including fluoropyrimidines, irinotecan, oxaliplatin, bevacizumab and/or cetuximab/panitumumab...
You likely can't join if
- Women who are pregnant or breastfeeding;
- Patients who have previously been treated with third-line regimens such as regorafenib, fruquintinib, trifluridine tipiracil, or other immune...
- Active autoimmune disease requiring systemic therapy within the past 2 years (e.g., treatment with disease-modifying drugs, corticosteroids...
- Active or prior history of definite inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea);
- Patients who have received intervention, ablation or radiotherapy within the previous 3 months for the target lesion;
- Patients with an expected survival time of less than 3 months;
See the full eligibility criteria
- Age \> 18 years old and \< 75 years old;
- ECOG Performance status score 0 or 1;
- Histologically or cytologically confirmed adenocarcinoma of colon or rectum, with liver metastases, with or without extrahepatic metastases;
- At least one measurable lesion as defined by RECIST version 1.1;
- Progressed or be intolerant to prior systemic therapy including fluoropyrimidines, irinotecan, oxaliplatin, bevacizumab and/or cetuximab/panitumumab (if RAS/RAF-wild-type);
- Known RAS and BRAF status;
- Only patients with mismatch repair-proficient (pMMR)/microsatellite stable (MSS) status;
- Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment: Liver and renal function: Total bilirubin ≤ 1.5× ULNl...
- Patients of childbearing potential must be willing to use highly effective contraception for the duration of the study and for ≥120 days after the last dose of cadonilimab; female patients with a negative urine or serum...
- Able to understand and voluntarily sign written informed consent;
- No history of allergy to regorafenib, cadonilimab and its components.
- Women who are pregnant or breastfeeding;
- Patients who have previously been treated with third-line regimens such as regorafenib, fruquintinib, trifluridine tipiracil, or other immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, anti-CTLA-4, or any...
- Active autoimmune disease requiring systemic therapy within the past 2 years (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants), replacement therapy (e.g., thyroxine, insulin, or...
- Active or prior history of definite inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea);
- Patients who have received intervention, ablation or radiotherapy within the previous 3 months for the target lesion;
- Patients with an expected survival time of less than 3 months;
- Study participants with other malignant tumors within 3 years prior to enrollment, excluding cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma...
- Patients with severe psychological or psychiatric abnormalities;
- No history of severe arrhythmia, heart failure, severe ventilatory dysfunction and severe lung infection, no acute and chronic renal failure;
- Concurrent enrollment in another clinical study, unless it is an observational, non-treatment clinical study or a follow-up period of an treatment study;
- Any other clinically significant disease or condition that, in the opinion of the investigator, may affect adherence to the protocol, or the signing of the Informed Consent Form (ICF) by the subject, or make...
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
- 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China; 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.