Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT07243951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Protocol Title: Phase II Clinical Trial on the Efficacy and Safety of the Combination of Cadonilimab and Capecitabine in Adjuvant Therapy for Combined Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma
Study Background and Rationale:
Combined hepatocellular-cholangiocarcinoma (cHCC/CCA) represents a rare primary liver malignancy exhibiting dual hepatocellular and cholangiocellular differentiation, accounting for approximately 0.4%-14.2% of all liver cancers. Despite R0 resection, postoperative recurrence rates remain exceedingly high (78.6% in reported series), with median overall survival of only 9-18 months. Currently, no standardized adjuvant therapy exists for cHCC/CCA following resection. This study investigates a novel combination strategy utilizing cadonilimab (a bispecific antibody targeting both PD-1 and CTLA-4) with capecitabine chemotherapy to address this unmet medical need by potentially enhancing antitumor immunity and eliminating micrometastatic disease in the postoperative setting.
Study Design:
This is a prospective, single-arm, open-label, multi-center phase II clinical study conducted under investigator initiation.
Intervention Protocol:
* Cadonilimab (AK104): 10 mg/kg administered via intravenous infusion over 60-120 minutes (minimum 60 minutes) on Day 1 of each 21-day cycle.
* Capecitabine: 2500 mg/m²/day administered orally in two divided doses within 30 minutes after morning and evening meals for 14 consecutive days followed by 7 days rest, constituting one 21-day cycle.
* Treatment Duration: Treatment continues for 8 cycles (24 weeks) unless terminated earlier due to: radiologically confirmed disease recurrence per RECIST 1.1, unacceptable toxicity, withdrawal of consent, or investigator decision.
Study Assessments:
* Tumor Evaluations: Radiological assessments (CT/MRI) performed every 12 weeks (4 cycles) during treatment. Post-treatment, patients without recurrence undergo imaging every 12 weeks until 24 months, followed by ultrasonography every 3 months with additional MRI/CT as clinically indicated.
* Safety Monitoring: Comprehensive safety assessments including adverse event monitoring (NCI-CTCAE v5.0), laboratory evaluations (hematology, biochemistry, coagulation, thyroid function), vital signs, physical examinations, and ECG performed at each cycle.
* Follow-up Schedule: Safety follow-up continues for 90 days after last cadonilimab dose or 30 days after last capecitabine dose. Survival follow-up conducted every 3 months (±14 days) via telephone or clinic visit after treatment completion.
Statistical Considerations:
The sample size of 75 patients was calculated to detect an improvement in median RFS from 12.2 months (historical control) to 18 months (HR=0.678) with 80% power at two-sided alpha=0.05, accounting for 5% drop-out rate. Efficacy analyses will utilize the Full Analysis Set (FAS) with Kaplan-Meier methodology for estimating RFS and OS, supplemented with 95% confidence intervals using Clopper-Pearson method.
Study Background and Rationale:
Combined hepatocellular-cholangiocarcinoma (cHCC/CCA) represents a rare primary liver malignancy exhibiting dual hepatocellular and cholangiocellular differentiation, accounting for approximately 0.4%-14.2% of all liver cancers. Despite R0 resection, postoperative recurrence rates remain exceedingly high (78.6% in reported series), with median overall survival of only 9-18 months. Currently, no standardized adjuvant therapy exists for cHCC/CCA following resection. This study investigates a novel combination strategy utilizing cadonilimab (a bispecific antibody targeting both PD-1 and CTLA-4) with capecitabine chemotherapy to address this unmet medical need by potentially enhancing antitumor immunity and eliminating micrometastatic disease in the postoperative setting.
Study Design:
This is a prospective, single-arm, open-label, multi-center phase II clinical study conducted under investigator initiation.
Intervention Protocol:
* Cadonilimab (AK104): 10 mg/kg administered via intravenous infusion over 60-120 minutes (minimum 60 minutes) on Day 1 of each 21-day cycle.
* Capecitabine: 2500 mg/m²/day administered orally in two divided doses within 30 minutes after morning and evening meals for 14 consecutive days followed by 7 days rest, constituting one 21-day cycle.
* Treatment Duration: Treatment continues for 8 cycles (24 weeks) unless terminated earlier due to: radiologically confirmed disease recurrence per RECIST 1.1, unacceptable toxicity, withdrawal of consent, or investigator decision.
Study Assessments:
* Tumor Evaluations: Radiological assessments (CT/MRI) performed every 12 weeks (4 cycles) during treatment. Post-treatment, patients without recurrence undergo imaging every 12 weeks until 24 months, followed by ultrasonography every 3 months with additional MRI/CT as clinically indicated.
* Safety Monitoring: Comprehensive safety assessments including adverse event monitoring (NCI-CTCAE v5.0), laboratory evaluations (hematology, biochemistry, coagulation, thyroid function), vital signs, physical examinations, and ECG performed at each cycle.
* Follow-up Schedule: Safety follow-up continues for 90 days after last cadonilimab dose or 30 days after last capecitabine dose. Survival follow-up conducted every 3 months (±14 days) via telephone or clinic visit after treatment completion.
Statistical Considerations:
The sample size of 75 patients was calculated to detect an improvement in median RFS from 12.2 months (historical control) to 18 months (HR=0.678) with 80% power at two-sided alpha=0.05, accounting for 5% drop-out rate. Efficacy analyses will utilize the Full Analysis Set (FAS) with Kaplan-Meier methodology for estimating RFS and OS, supplemented with 95% confidence intervals using Clopper-Pearson method.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: