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SBRT Combined With Adbelimumab and Apatinib for Perioperative and Conversion Therapy of Hepatocellular Carcinoma

ConditionsHepatocellular CarcinomaSBRTImmune Checkpoint BlockadeTyrosine Kinase Inhibitor
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFujian Cancer Hospital

About this trial

This is a Phase II , Open-label , Investigator-initiated Trail of SBRT in Combination With Adbelimumab and Apatinib in Patients With Hepatocellular Carcinoma(HCC).This study aims to evaluate the safety and efficacy of SBRT in Combination With Adbelimumab and Apatinib as a preoperative and conversion treatment of HCC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient volunteered to participate in the study and signed an informed consent form

≥18 years of age，Male or female

Subjects are diagnosed with histologically or cytologically confirmed HCC

Subjects haven't received any systemic treatment for HCC before admission.

Disqualifiers

Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously

Be ready for or previously received organ or allogenic bone marrow transplantation

Moderate-to-severe ascites with clinical symptoms

History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage.

Trial design

Design model

Parallel

Treatments tested in this trial

  • adbelimumab

    Drug

    adbelimumab：1200mg iv d1 q3w

  • SBRT

    Procedure/Surgery

    SBRT: SBRT: 8-30Gy/1-6F（dose is determined according to the tumor diameter）; tumor thrombus dose 30Gy /5-6F;

  • apatinib

    Drug

    apatinib：250mg po, qd

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Perioperative queueExperimental treatment 3 interventions
Group B: Conversion queueExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response Rate (Perioperative cohort)

No histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors

Time frame
4 months
2

Objective Response (Conversion cohort)

It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR.

Time frame
12 months

Secondary outcomes

1

Event-free survival

Refers to the time from the start of the group to the occurrence of any event

Time frame
5 year
2

Major pathologic response

It is defined as residual tumors less than 10% after neo-adjuvant therapy

Time frame
4 months
3

Overall survival

It is defined as the time from randomization to death from any cause during the course of the study

Time frame
5 year
4

Safety as measured by the rate of AEs

Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs)

Time frame
1 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

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