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Not yet recruiting NCT06739317

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

Phase II / Phase III Interventional Unresectable Hepatocellular Carcinoma (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiation, First line therapy, First line therapy, operation.
Who it may be relevant to
Registry conditions: Unresectable Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

•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.

Overview

•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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Overall Survival [Time frame: Up to approximately 3 years]
  • The R0 Resection rate of the experimental group [Time frame: Up to approximately 30 days]
Secondary outcome measures (12)
  • Objective Response Rate (ORR) [Time frame: Up to approximately 3 years]
  • Disease control rate (DCR) [Time frame: Up to approximately 3 years.]
  • Time to Response (TTR) [Time frame: Up to approximately 3 years.]
  • Duration of response (DoR) [Time frame: Up to approximately 3 years.]
  • Time to progression (TTP) [Time frame: Up to approximately 3 years.]
  • Event free survival (EFS) [Time frame: Up to approximately 3 years.]
  • Conversion rate [Time frame: Up to approximately 30 days.]
  • Resection rate [Time frame: Up to approximately 30 days.]
  • R0 resection rate [Time frame: Up to approximately 30 days.]
  • Pathologic complete response (pCR) rate [Time frame: Up to approximately 30 days.]
  • Major pathological response (MPR) [Time frame: Up to approximately 30 days.]
  • Safety [Time frame: Up to approximately 90 days.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • the First Affiliated Hospital of Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT06739317 · MA-HCC-II/III-030

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗