Title: A Study of Cadonilimab Combined with Capecitabine After Surgery for Mixed Type Liver Cancer
This is a phase II clinical trial. The main purpose of this study is to find out if using two drugs together, cadonilimab (an immunotherapy drug) and capecitabine (a chemotherapy drug), can help prevent the cancer from coming back after surgery in patients with a specific type of liver cancer called combined hepatocellular-cholangiocarcinoma (cHCC/CCA). This type of liver cancer is rare and has a high chance of returning even after successful surgery.
The study will involve about 75 patients who have had their tumor completely removed but are still at medium to high risk of the cancer returning. All participants in the study will receive the same combination of drugs. Cadonilimab is given through a vein every three weeks. Capecitabine is taken as a pill twice a day for two weeks, followed by one week off. This cycle repeats for up to 8 cycles (about 6 months), or until the cancer comes back or side effects become too severe.
Researchers will primarily measure how long patients live without the cancer returning (Recurrence-Free Survival). They will also track how long patients live overall (Overall Survival), and carefully record any side effects to understand the safety of this treatment combination.
The study hypothesis is that this combination therapy will significantly prolong RFS compared to historical outcomes with surgery alone, while demonstrating acceptable safety.
Age 18-75 years.
ECOG Performance Status ≤ 1.
Pathologically confirmed combined hepatocellular carcinoma and intrahepatic cholangiocarcinoma (cHCC/CCA), with R0 resection and classified as Stage IB, Stage II, Stage IIIA, Stage IIIB, or Stage IA (G3) according to AJCC TNM Staging System (8th Edition, 2017).
No extrahepatic metastasis.
Pathological diagnosis of hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), or hilar cholangiocarcinoma.
Incomplete tumor resection (non-R0), or postoperative pathology indicating a diagnosis other than cHCC/CCA.
History of or concurrent other malignancies, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc. Concurrent autoimmune diseases (e.g., autoimmune liver disease, systemic lupus erythematosus).
Child-Pugh class B or C; history or presence of manifestations of hepatic decompensation (e.g., ascites, hepatic encephalopathy, upper gastrointestinal bleeding, etc.).
Single group
Cadonilimab
DrugCadonilimab is a bispecific monoclonal antibody targeting both PD-1 and CTLA-4. It will be administered intravenously at a dose of 10 mg/kg over 60-120 minutes (no less than 60 minutes) on Day 1 of each 3-week cycle.
Capecitabine
DrugCapecitabine is an oral chemotherapeutic prodrug that is converted to 5-fluorouracil in the body. The dose is 2500 mg/m² per day, administered orally in two divided doses (morning and evening) within 30 minutes after a meal. It is given for 2 weeks followed by a 1-week rest, constituting one 3-week cycle.
Recurrence-Free Survival (RFS)
The length of time after primary treatment for cancer ends that the patient survives without any signs or symptoms of that cancer. Tumor recurrence or metastasis will be determined based on radiological imaging (CT or MRI) and evaluated according to RECIST 1.1 criteria.
Overall Survival (OS)
The length of time from the start of treatment that patients are still alive. It is a direct measure of the clinical benefit of the treatment.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The safety and tolerability of the combination therapy will be assessed by monitoring the type, frequency, severity, and relationship to study drugs of all adverse events and serious adverse events. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
PD-L1 Expression Level in Tumor Tissue
An exploratory biomarker analysis to evaluate the level of programmed death-ligand 1 (PD-L1) protein expression in archival tumor tissue samples obtained during surgery and its potential association with clinical outcomes.
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