Health TrialsbyHealthPanel

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

ConditionUnresectable Hepatocellular Carcinoma (HCC)
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • First line therapy

    Drug

    Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.

  • operation

    Procedure/Surgery

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

Treatment groups

398 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 3 interventions
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

The primary endpoint of phase 3 study is OS

Time frame
Up to approximately 3 years
2

The R0 Resection rate of the experimental group

The primary endpoint of phase 2 study is the R0 Resection rate of the experimental group

Time frame
Up to approximately 30 days

Secondary outcomes

1

Objective Response Rate (ORR)

The ORR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.

Time frame
Up to approximately 3 years
2

Disease control rate (DCR)

The DCR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.

Time frame
Up to approximately 3 years.
3

Time to Response (TTR)

The TTR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.

Time frame
Up to approximately 3 years.
4

Duration of response (DoR)

The DoR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.

Time frame
Up to approximately 3 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: