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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Candonilimab
DrugCandonilimab 10mg/kg, Ivgtt，Q3W，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；
Cisplatin
DrugCisplatin，25mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；
Gemcitabine
Druggemcitabine 1000mg/m2，Ivgtt，Dosing on days 1 and 8，Every 21 days is a cycle, administered on the first day of each cycle, and used continuously；
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: Candonilimab in combination with cisplatin and gemcitabineExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Objective response rate(ORR)
Defined as the proportion of the subjects who have a complete response (CR) and partial response (PR) per RECIST 1.1 in enrolled subjects
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame
through study completion, an average of 1 yearOther outcomes
1
overall survival (OS)
To evaluate the overall survival (OS) in order to assess the efficacy and safety of Candonilimab in combination with cisplatin and gemcitabine treatment.
Time frame
through study completion, an average of 1 year2
progression free survival (PFS)
To evaluate the progression free survival (PFS) in order to assess the efficacy and safety of Candonilimab in combination with cisplatin and gemcitabine treatment.
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov