TACE Plus Camrelizumab and Apatinib for Unresectable Hepatocellular Carcinoma

NCT06485466 | Recruiting Phase 3

• 1 other identifier: IIT2024041
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most common cause of cancer-related death worldwide. The majority of patients with HCC are diagnosed as intermediate or advanced stage disease, and not eligible for curative treatments including transplantation, resection, and ablation. Transarterial chemoembolization (TACE) is recommended as first-line treatment for patients with intermediate-stage HCC, while it is also widely used in the unresectable HCC. The clinical efficacy and safety in advanced HCC patients of camrelizumab plus apatinib were reported in phase 3 trial (CARES-310). Camrelizumab plus apatinib with a median progression-free survival of 5.7 months and a median overall survival of 22.1 months in advanced HCC. This study is randomized, open-label, multicenter controlled trial; which was focused in initial BCLC-B/C HCC patients. This study aimed to compare the efficacy and safety of TACE plus programmed death-1 inhibitor (camrelizumab), and anti-angiogenic therapy (apatinib) with camrelizumab plus apatinib.

Conditions

Unresectable Hepatocellular Carcinoma; Transarterial Chemoembolization; Camrelizumab; Apatinib

Outcome Measures

Primary Outcomes (1)

• progression free survival (PFS)

  Progression free survival period refers to the period from the beginning of treatment to the time when patients with cancer progress is observed or death occurs for any reason.

  Up to 24 months, from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcomes (3)

• objective response rate (ORR)

  within 1 year

• disease control rate (DCR)

  within 1 year

• overall survival (OS)

  From date of randomization until the date of study completion or date of death from any cause, whichever came first, assessed up to 48 months

Study Arms (2)

TACE plus camrelizumab and apatinib

EXPERIMENTAL

Procedure: TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery.Adriamycin(30 to 60 mg) and oxaliplatin (50-150mg) are considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion. The dose of lipiodol (5-20ml) and other embolic agent( blank microspheres/ PVA/gelatin sponge particles) were determined by diameter and blood supply type of HCC. Camrelizumab+apatinib: camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily.

Combination Product: TACE plus camrelizumab and apatinib

Camrelizumab plus apatinib

ACTIVE COMPARATOR

Camrelizumab+apatinib: camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily.

Combination Product: Camrelizumab and apatinib

Interventions

TACE plus camrelizumab and apatinib COMBINATION_PRODUCT

TACE plus camrelizumab and apatinib group: Patients who were randomized to this group, TACE is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery.Adriamycin(30 to 60 mg) and oxaliplatin (50-150mg) are considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion. The dose of lipiodol (5-20ml) and other embolic agent( blank microspheres/ PVA/gelatin sponge particles) were determined by diameter and blood supply type of HCC. Within 1 week after first TACE treatment, camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily.

TACE plus camrelizumab and apatinib

Camrelizumab and apatinib COMBINATION_PRODUCT

Camrelizumab and apatinib group: Patients who were randomized to this group, camrelizumab 200mg intravenously every 3 weeks and apatinib 250 mg orally once daily.

Camrelizumab plus apatinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically or clinically confirmed hepatocellular carcinoma
• years old.
• Performance status (PS) ≤ 1 (ECOG scale).
• Barcelona clinical liver cancer (BCLC) stage B or stage C.
• Initial treatment of hepatocellular carcinoma.
• According to mRECIST, there is at least one measurable lesion.
• Child Pugh score ≤ 7.
• Participant has sufficient organ and marrow functions.
• Expected survival time ≥ 12 weeks.
• For women of childbearing age or male patients whose sexual partners are women of childbearing age, effective contraceptive measures should be taken during the whole treatment period and 6 months after the last medication.
• Sign the written informed consent, and be able to follow the visit and relevant procedures specified in the plan.

You may not qualify if:

• Fibrolamellar carcinoma, sarcomatoid carcinoma, cholangiocarcinoma and other components previously confirmed by histology / cytology.
• History of hepatic encephalopathy or liver transplantation.
• Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage.
• Tumor burden≥70%, diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.
• Received local treatment (ablation therapy, TACE), surgery resection and radiotherapy for liver cancer before the first administration.
• Have received systemic chemotherapy, targeted therapy or immunotherapy
• There is a significant decrease in white blood cells and platelets in peripheral blood, severe coagulation dysfunction and can not be corrected：the neutrophil\<1.5×109/L, PLT\<50×109/L. The INR\>2.3
• Acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV-DNA) \> 10\^6 copies / ml; hepatitis C virus (HCV-RNA) \> 10\^3 copies / ml; HBsAg and anti HCV antibody were positive at the same time.
• There is central nervous system metastasis.
• Bleeding of esophageal or gastric varices caused by portal hypertension occurred in the past 6 months, or severe (G3) varices were found in endoscopic examination within 3 months before the first administration, or evidence of portal hypertension (including splenomegaly found in imaging examination) was found. The researchers assessed that the risk of bleeding was high and did not receive sclerotherapy or ligation under the endoscope.
• The previous 6-month history of arteriovenous thromboembolism, including myocardial infarction, unstable angina, cerebrovascular accident, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism. The thrombus of implanted vein port or catheter source or superficial vein is stable after routine anticoagulant treatment. Prophylactic use of low-molecular-weight heparin (e.g., enoxaparin 40 mg / day) is permitted.
• Tumor thrombus of main portal vein, or involving superior mesenteric vein at the same time.
• Aspirin (\> 325 mg / day) or other drugs known to inhibit platelet function such as dipyridamole or clopidogrel were used for 7 consecutive days within 2 weeks before the first administration.
• For uncontrolled hypertension, systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg after the best medical treatment, hypertension crisis or hypertension encephalopathy history.
• Symptomatic congestive heart failure (New York Heart Association class II-IV). Symptomatic or poorly controlled arrhythmias. The corrected QT interval (QTc) for the history or screening of congenital long QT syndrome was more than 500 ms (calculated by Fridericia method).

Sponsors & Collaborators

• Guohui Xu: lead

Study Sites (1)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; apatinib

Study Officials

• Guohui Xu

  Sichuan Cancer Hospital and Research Institute

  STUDY CHAIR

Central Study Contacts

Xuegang Yang, MD

CONTACT

+8613683476844; yanggangxue@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: July 3, 2024
• Study Start: August 10, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CN (1)