Cadonilimab Combined With Regorafenib as A Third-line Treatment in Patients With MSS CRLM
ConditionCRC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJin-hong Chen
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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 cellular immunotherapy;
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 physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment;
Active or prior history of definite inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea);
Trial design
Treatments tested in this trial
- Candonilimab (AK104)
- Regorafenib
Treatment groups
44 Participants
are divided into 1 treatment groupSponsors and collaborators
Jin-hong Chen
Lead sponsor
Fudan University
Sponsor institution
Source ClinicalTrials.gov