Camrelizumab, Apatinib Plus HAIC Versus Camrelizumab and Apatinib for HCC With Portal Vein Invasion: a Randomized Trial

NCT05198609 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: MA-HCC-II-013
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the efficacy and safety of camrelizumab, apatinib plus FOLFOX-HAIC and camrelizumab plus apatinib in hepatocellular carcinoma with portal vein invasion.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma, hepatic arterial infusion chemotherapy, immunotherapy, targeted therapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  the The date of randomization to death from any cause

  2 months

Secondary Outcomes (6)

• Progression-free survival

  2 months

• Time to progression

  2 months

• Time to response

  2 months

• Duration of response

  2 months

• Objective response rate

  2 months

Study Arms (2)

Camrelizumab, Apatinib Plus FOLFOX-HAIC

EXPERIMENTAL

Procedure: FOLFOX-HAIC; Drug: Camrelizumab; Drug: Apatinib

Camrelizumab and Apatinib

ACTIVE COMPARATOR

Drug: Camrelizumab; Drug: Apatinib

Interventions

FOLFOX-HAIC PROCEDURE

Hepatic arterial infusion of oxaliplatin (85mg/m2,IA,day 1, hour 0-2), fluorouracil (400mg/m2,IA,day 1, hour 3), leucovorin (400mg/m2, IV,day 1, hour 2-3) and fluorouracil (2400mg/m2, IA, hour 3-23) repeated every 4 weeks for a total of six times

Camrelizumab, Apatinib Plus FOLFOX-HAIC

Camrelizumab DRUG

Camrelizumab was administered 200mg intravenously for 30-60 minutes every 2 weeks, and the maximum cumulative duration of Camrelizumab is 2 years. The shortest time interval between two administrations should not be less than 12 days.

Camrelizumab and Apatinib; Camrelizumab, Apatinib Plus FOLFOX-HAIC

Apatinib DRUG

Apatinib was administered orally 250mg once per day

Camrelizumab and Apatinib; Camrelizumab, Apatinib Plus FOLFOX-HAIC

Eligibility Criteria

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

You may qualify if:

• volunteered with written inform consent
• unresectable HCC or progression after surgery or locoregional threapy, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases practice guidelines and the China liver cancer (CNLC) guidelines
• Patients with portal vein tumor thrombosis (PVTT) confirmed by 2 kinds of imaging examinations
• no previous systemic therapy for HCC. Herbs, Chinese medicines or proprietary Chinese medicines that contain anti-cancer active ingredients in the instructions are allowed, but such treatments need to be terminated before randomization
• at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• patients who had previously received local treatments (such as radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, trans-arterial chemoembolization, trans-arterial embolization, etc.)were allowed to be enrolled, but it was required that the target lesions were with no previous local treatment, or the target lesion had received local treatment but had progression according to the RECIST v1.1
• an Eastern Cooperative Oncology Group performance status of 0 to 1
• Child-Pugh A class liver function
• adequate organ function (absoluteneutrophil count ≥1.5 × 109/L, platelet count ≥75 × 109/L, hemoglobin ≥ 90g/L, ALB≥30g/L, TBIL ≤30 umol/L, AST ≤5×ULN, ALT ≤5×ULN, ALP ≤5×ULN, Cr ≤1.5×ULN, TSH≤1×ULN and TSH≥LLN, INR≤2.3, prolonged PT≤6s without anticoagulant therapy, urine protein \<2+ or urine protein ≥2+ but 24h urine protein quantitative \<1.0 g)
• patients with HBsAg (+) received anti-viral therapy, and patients with HCV-RNA (+) must received anti-viral therapy according to the guidelines and the liver function increases within CTCAE grade 1 during the study
• Female with fertility must agree to use reliable methods of contraception from the signing of the informed consent until at least 120 days after the last administration of the study drug. And the serum HCG test must be negative within 7 days before the start of the study treatment; and it must be a non-lactating period.
• For male patients whose partner is a fertile woman, they must agree to use reliable methods of contraception from the signing of the informed consent until at least 120 days after the last administration of the study drug. During the same period of time, male patients must also agree not to donate sperm.

You may not qualify if:

• intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma diagnosised by pathology
• patients with other malignant tumors except HCC within 5 years or at the same time, except for cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc.
• patients who are planning to undergo or have previously received organ or allogeneic bone marrow transplantation
• history of hepatic encephalopathy
• moderate and severe ascites with clinical symptoms and uncontrolled pleural effusion and pericardial effusion
• a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding within 6 months before the start of the study treatment
• a history of abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the start of study treatment
• a known hereditary or acquired bleeding (such as coagulopathy) or thrombotic tendency
• currently using or recently used (within 10 days before the start of the study treatment) anticoagulant drugs
• thrombosis or embolism occurred within 6 months before the start of study treatment, such as cerebrovascular accident, pulmonary embolism
• with clinical symptoms or diseases of the heart that are not well controlled
• suffered from blood pressure that could not be well controlled by antihypertensive medication or a history of hypertensive crisis or hypertensive encephalopathy
• severe cardiovascular disease occurred within 6 months before the start of study treatment
• severe, unhealed or dehisced wounds and active ulcers or untreated fractures
• received major surgery (except for diagnosis) within 4 weeks before the start of the study treatment or is expected to undergo major surgery during the study period

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First People's Hospital of Foshan: collaborator
• Zhongshan People's Hospital, Guangdong, China: collaborator
• Affiliated Hospital of Guangdong Medical University: collaborator
• Shandong Provincial Hospital: collaborator

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

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

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 20, 2022
• Study Start: January 17, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (1)