SBRT Combined with Camrelizumab and Apatinib for Conversion Therapy in Patients with Unresectable Hepatocellular Carcinoma.

December 12, 2024 updated by: Ming Kuang, Sun Yat-sen University

•Stereotactic Body Radiotherapy Combined with Camrelizumab and Apatinib As Conversion Therapy Versus Camrelizumab Combined with Apatinib As First-Line Therapy for Unresectable Hepatocellular Carcinoma: a Prospective, Multicenter, Open-label, Randomized Controlled Clinical Trial.

•This is a randomized, open-label, multi-center, phases 2 and phase 3 trial to evaluate the efficacy and safety of SBRT combined with Camrelizumab and Apatinib as conversion therapy versus Camrelizumab combined with Apatinib as first-Line therapy for unresectable hepatocellular carcinoma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

398

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lixia Xu
  • Phone Number: +86-020-87755766

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed Informed Consent Form (ICF).
  • Aged 18 years or older.
  • Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
  • Barcelona Clinic Liver Cancer stage B or C disease, which was not amenable to radical surgery.
  • ECOG Performance Status of 0 or 1.
  • Child-Pugh class of A.

Exclusion Criteria:

  • Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously.
  • Existence of active autoimmune disease or history of autoimmune disease and may relapse.
  • Patients with innate or acquired immune deficiency (e.g., HIV infection).
  • Known allergies to study drugs or excipients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Drug: First line therapy
Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.
Experimental: Experimental group
Radiation: Radiation
Subjects receive Stereotactic Body Radiotherapy combined with Camrelizumab and Apatinib as conversion therapy.
Drug: First line therapy
Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.
Procedure: operation
If subjects suitable for hepatic resection after conversion therapy, radical surgery and postoperative adjuvant therapy will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to approximately 3 years
The primary endpoint of phase 3 study is OS
Up to approximately 3 years
The R0 Resection rate of the experimental group
Time Frame: Up to approximately 30 days
The primary endpoint of phase 2 study is the R0 Resection rate of the experimental group
Up to approximately 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 3 years
The ORR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Up to approximately 3 years
Disease control rate (DCR)
Time Frame: Up to approximately 3 years.
The DCR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Up to approximately 3 years.
Time to Response (TTR)
Time Frame: Up to approximately 3 years.
The TTR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Up to approximately 3 years.
Duration of response (DoR)
Time Frame: Up to approximately 3 years.
The DoR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Up to approximately 3 years.
Time to progression (TTP)
Time Frame: Up to approximately 3 years.
The TTP is assessed by The investigators according to RECIST v1.1 and mRECIST,
Up to approximately 3 years.
Event free survival (EFS)
Time Frame: Up to approximately 3 years.
The EFS is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Up to approximately 3 years.
Conversion rate
Time Frame: Up to approximately 30 days.
The conversion rate of the experimental group.
Up to approximately 30 days.
Resection rate
Time Frame: Up to approximately 30 days.
The resection rate of the experimental group.
Up to approximately 30 days.
R0 resection rate
Time Frame: Up to approximately 30 days.
The R0 resection rate of the experimental group.
Up to approximately 30 days.
Pathologic complete response (pCR) rate
Time Frame: Up to approximately 30 days.
The pCR rate of the experimental group.
Up to approximately 30 days.
Major pathological response (MPR)
Time Frame: Up to approximately 30 days.
The MPR rate of the experimental group.
Up to approximately 30 days.
Safety
Time Frame: Up to approximately 90 days.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Up to approximately 90 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

June 30, 2031

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-HCC-II/III-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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