Phase II Clinical Study on the Efficacy and Safety of the Combination of Cadonilimab and Capecita… (NCT07243951) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Clinical Study on the Efficacy and Safety of the Combination of Cadonilimab and Capecitabine in Adjuvant Therapy for Combined Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma
75 participantsStarted 2025-11-28
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Post-operative Child-Pugh liver function class A; ECOG PS score: 0-1.
✓. For subjects with chronic HBV infection, HBV-DNA must be \<500 IU/mL. HBsAg-positive patients must receive antiviral therapy according to the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015)". HCV-RNA positive patients must receive antiviral therapy according to the "Guidelines for the Prevention and Treatment of Hepatitis C (2015)" and have normal liver function.
✓. Adequate organ function, defined as follows:
✓. Hemoglobin (HB) ≥90 g/L
Exclusion criteria
What they're measuring
1
Recurrence-Free Survival (RFS)
Timeframe: From the start of treatment until the date of first documented recurrence, metastasis, or death from any cause.ssessed regularly every 12 weeks (every 4 cycles) during treatment, then every 12 weeks until 24 months after treatment completion.
. 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.).
✕. Known hereditary or acquired bleeding or thrombotic tendencies, such as hemophilia.
✕. Presence of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 2 months prior to study participation.
✕. Myocardial ischemia of grade II or above, myocardial infarction, or poorly controlled arrhythmias (including QTcF interval ≥450 ms for males or ≥470 ms for females; QTc interval calculated by Fridericia's formula). Cardiac insufficiency of NYHA Class III-IV or left ventricular ejection fraction (LVEF) \<50% on echocardiography.
✕. Severe cardiopulmonary dysfunction or severe renal insufficiency.