The Synergistic Effect of Portal Venous Supply Control and Immunotherapy in Hepatocellular Carcinoma

NCT05760430 | Unknown Phase 2

• 1 other identifier: 2022-0857
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma is one of the most common solid malignant tumors. The prognosis of unresectable hepatocellular carcinoma is very poor. According to the current literature and the clinical practice of our center, portal vein blood supply control may have great potential in the synergistic treatment of unresectable hepatocellular carcinoma. Thus, we hope to study the safety and efficacy of portal blood supply control +TACE+ Camrelizumab + Apatinib combined therapy in initial unresectable hepatocellular carcinoma through a single-center clinical trial, and explore the synergistic effect of portal blood flow control in target immune therapy of hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Portal Venous Supply Control; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Conversion rate

  The proportion of patients with unresectable hepatocellular carcinoma who have achieved surgical R0 resection after combined treatment.

  The time frame is from the first treatment to the last treatment, an average of 2 years.

Secondary Outcomes (5)

• Objective response rate

  The time frame is from the first treatment to the last treatment, an average of 2 years.

• Residual liver volume proliferation rate after hepatectomy

  The time frame is from the first treatment to the last treatment, an average of 2 years.

• Progression-free survival

  The time frame is from the first treatment to the last treatment, an average of 2 years.

• Time to progress

  The time frame is from the first treatment to the last treatment, an average of 2 years.

• Overall survival

  The time from the first treatment to death (up to 3 years). The last follow-up time is for the patients who lost the follow-up, and the end of the follow-up is for the patients who are still alive at the end of the study.

Study Arms (2)

Experimental Group

EXPERIMENTAL

After cTACE, 3 mg/kg of Camrelizumab was injected intravenously once every three weeks+250 mg of Apatinib mesylate tablets were taken orally once a day. PVE was performed on the half liver with the largest tumor load 2 weeks after CTACE.

Combination Product: PVE+cTACE+Camrelizumab+Apatinib

Control group

ACTIVE COMPARATOR

After cTACE, 1200 mg of Atirizumab+15 mg/kg of Bevacizumab was injected intravenously every three weeks.

Combination Product: cTACE+Atirizumab+Bevacizumab

Interventions

PVE+cTACE+Camrelizumab+Apatinib COMBINATION_PRODUCT

After cTACE, 3 mg/kg of Camrelizumab was injected intravenously once every three weeks+250 mg of Apatinib mesylate tablets were taken orally once a day. PVE was performed on the half liver with the largest tumor load 2 weeks after CTACE.

Experimental Group

cTACE+Atirizumab+Bevacizumab COMBINATION_PRODUCT

After cTACE, 1200 mg of Atirizumab+15 mg/kg of Bevacizumab was injected intravenously every three weeks.

Control group

Eligibility Criteria

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

You may qualify if:

• Adult male or female aged ≥ 18;
• Primary hepatocellular carcinoma confirmed by pathology;
• There is no extrahepatic metastasis and portal vein tumor thrombus (Barcelona stage b), which cannot be removed after the evaluation of the surgeon, but there is a potential surgical opportunity after the tumor is significantly reduced;
• Have not received treatment in the past;
• At least 1 measurable lesion meeting the RECIST v1.1 or mRECIST standard;
• Liver function is Child-Pugh A;
• ECOG PS 0\~1 before entering the group;
• Organs and bone marrow are fully functional:
• Expected survival period ≥ 3 months; 10. Women of childbearing age who have not undergone surgical sterilization should take effective contraceptive measures within 3 months from enrollment to the end of the trial; 11. Sign a written informed consent and be able to comply with the visit and relevant procedures specified in the plan.

You may not qualify if:

• The patient has any history of active autoimmune disease or autoimmune disease;
• The patient is using immunosuppressant or systemic hormone therapy to suppress immune function;
• Known central nervous system metastasis or hepatic encephalopathy;
• Severe allergic reaction to other monoclonal antibodies;
• Have a history of organ transplantation;
• The patient has the serious basic disease and cannot tolerate treatment;
• The patient has previously received other anti-PD-1 antibody treatment or other anti-PD-1/PD-L1 immunotherapy, or has previously received apatinib treatment;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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 Officials

• Sheng Yan, Dctor

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY CHAIR

Central Study Contacts

Sheng Yan, Doctor

CONTACT

13957161680; shengyan@zju.edu.cn

Xi Ma, Dctor

CONTACT

18768117002

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 8, 2023
• Study Start: December 14, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 8, 2023

Record last verified: 2022-12

Locations

CN (1)