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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

NCT07243951 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-11-24

No results posted yet for this study

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.

Conditions

  • Combined Hepatocellular-cholangiocarcinoma
  • Liver Neoplasms

Interventions

DRUG

Cadonilimab

Cadonilimab 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.

DRUG

Capecitabine

Capecitabine 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.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-28
Primary Completion
2026-12-31
Completion
2028-06-30

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07243951 on ClinicalTrials.gov