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NCT Number: NCT06739317

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

•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.

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Key information

Conditions

Unresectable Hepatocellular Carcinoma (HCC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiation

Radiation

Subjects receive Stereotactic Body Radiotherapy combined with Camrelizumab and Apatinib as conversion therapy.

First line therapy

Drug

Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.

Operation

Procedure

If subjects suitable for hepatic resection after conversion therapy, radical surgery and postoperative adjuvant therapy will be performed.

Primary outcomes

  1. Overall Survival

    Time frame: Up to approximately 3 years

    The primary endpoint of phase 3 study is OS

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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,

  6. 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.

  7. Conversion rate

    Time frame: Up to approximately 30 days.

    The conversion rate of the experimental group.

  8. Resection rate

    Time frame: Up to approximately 30 days.

    The resection rate of the experimental group.

  9. R0 resection rate

    Time frame: Up to approximately 30 days.

    The R0 resection rate of the experimental group.

  10. Pathologic complete response (pCR) rate

    Time frame: Up to approximately 30 days.

    The pCR rate of the experimental group.

  11. Major pathological response (MPR)

    Time frame: Up to approximately 30 days.

    The MPR rate of the experimental group.

  12. Safety

    Time frame: Up to approximately 90 days.

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Lixia Xu

CONTACT

+86-020-87755766

Ming Kuang

CONTACT

[email protected]

+86-020-87755766

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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