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Sequential FOLFOX-HAIC-TACE Plus Sintilimab-Bevacizumab Neoadjuvant Therapy Versus Direct Resection in Resectable High-Risk Recurrence Hepatocellular Carcinoma

ConditionHepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBinYong Liang

About this trial

This study is designed to evaluate the efficacy and safety of sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE as the perioperative adjuvant therapy in surgical resection to hepatocellular carcinoma with high-risk features. (1) Evaluate for some high-risk patients with resectable tumours, whether or not sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE reduces the risk of recurrence and improves the survival of patients. (2) Evaluate the safety of sintilimab-bevacizumab doublet combined with FOLFOX-HAIC and TACE for the neoadjuvant therapy of resectable hepatocellular carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Pregnant or lactating women;

Patients with a history of other malignancies within the past 5 years, excluding basal cell carcinoma of the skin， cervical carcinoma in situ and/or thyroid papillary carcinoma have been cured;

Patients who are known to be allergic to the trial drugs, finolizumab and bevacizumab；

Previous history of upper gastrointestinal bleeding or current presence of a clear bleeding risk disease;

Trial design

Design model

Parallel

Treatments tested in this trial

  • FOLFOX regimen

    Drug

    oxaliplatin 85 mg/m² intra-arterial infusion over 2 hours; leucovorin calcium 200 mg/m² intra-arterial infusion over 2 hours; 5-fluorouracil 400 mg/m² intra-arterial bolus followed by 2400 mg/m² continuous intra-arterial infusion over 46 hours

  • Immunotherapy

    Drug

    sintilimab (200 mg intravenous infusion, q3w)

  • targeted therapy

    Drug

    bevacizumab (15 mg/kg intravenous infusion, q3w)

  • cTACE

    Device

    conventional transarterial chemoembolization

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group A（ Intervention group)Experimental treatment 4 interventions
Group B: Group B ( Control group)Other 1 intervention

Trial outcomes

Primary outcomes

1

2y-RFS

2-year recurrence-free survival rate

Time frame
From date of randomization until date of first documented recurrence or death from any cause, whichever occurs first, assessed up to 2 years

Secondary outcomes

1

pCR

pathological Complete Response，defined as the absence of residual invasive tumor cells in the primary tumor and regional lymph nodes in the resected specimen after neoadjuvant therapy.

Time frame
Perioperative
2

MPR

Major Pathological Response，presence of viable tumor cells ≤30% in the primary tumor and lymph nodes after radical resection

Time frame
Perioperative
3

ORR

Objective Response Rate，the proportion of patients who achieved complete response (CR) or partial response (PR) in tumor shrinkage according to the mRECIST v1.1 criteria and maintained the response for at least 8 weeks

Time frame
Perioperative
4

R0 resection rate

The proportion of patients who achieved radical R0 resection among those who underwent surgery.

Time frame
Perioperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

BinYong Liang

Lead sponsor

Tongji Hospital

Sponsor institution

Beijing Bethune Charitable Foundation

Collaborator

Source ClinicalTrials.gov

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