Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer
ConditionCholangiocarcinoma Non-resectable
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital
About this trial
The goal of this single-arm, Phase II interventional clinical trial is to test the safety and effectiveness of a combination treatment using the Cadonilimab with Gemcitabine and Cisplatin in patients with unresectable, locally advanced or metastatic biliary tract malignancies. The main questions it aims to answer are:
* Is this combined treatment protocol safe for these patients? * Is this combined treatment protocol effective in treating these patients?
Participants will be given a combination treatment of Cadonilimab, Gemcitabine, and Cisplatin. Researchers will monitor their health conditions to assess the safety and effectiveness of this treatment protocol.
Eligibility criteria
Qualifiers
Obtain written informed consent before implementing any experimental procedures.
Age between 18 and 75 years (any gender).
Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tumors (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma).
No prior systemic treatment, curative surgery, or adjuvant therapy allowed within the past 6 months.
Disqualifiers
Diagnosis of malignant diseases other than extrahepatic bile duct cancer, excluding completely resected basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma within the past 5 years.
Tumors located in the ampulla of Vater.
Currently participating in an interventional clinical study or received other investigational drugs or investigational device treatment within 4 weeks prior to the first dose of study drug.
Previously received therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting another T-cell receptor with inhibitory or co-stimulatory function (e.g., CTLA-4, OX-40, CD137).
Trial design
Treatments tested in this trial
- Candonilimab
- Cisplatin
- Gemcitabine
Treatment groups
65 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov