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

NCT06538935 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: HCC
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatocellular Carcinoma; SBRT; Immune Checkpoint Blockade; Tyrosine Kinase Inhibitor

Outcome Measures

Primary Outcomes (2)

• Pathological complete response Rate (Perioperative cohort)

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

  4 months

• 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.

  12 months

Secondary Outcomes (4)

• Event-free survival

  5 year

• Major pathologic response

  4 months

• Overall survival

  5 year

• Safety as measured by the rate of AEs

  1 month

Study Arms (2)

Perioperative queue

EXPERIMENTAL

SBRT: SBRT: 8-30Gy/1-6F（dose is determined according to the tumor diameter）； Adbelimumab: 2-3 cycles of neoadjuvant therapy before surgery, 1200mg iv d1 q3w; Apatinib : D1-D21 : 250 mg, orally, qd; Before surgery, the patient's surgical pathology samples still need to be collected. After surgery, patients would receive Adbelimumab and Apatinib as adjuvant therapy .No more than 17 cycles before and after surgery.

Drug: adbelimumab; Procedure: SBRT; Drug: apatinib

Conversion queue

EXPERIMENTAL

SBRT: tumor thrombus dose 30Gy /5-6F; Primary tumor dose is referred to Perioperative queue; Adbelimumab: 1200mg iv d1 q3w; Apatinib : D1-D21 : 250 mg, orally, qd; Treatment continues till PD,death,intolerable toxicity,or meet the criteria for Successful transformation(the maximum duration of adbelizumab combined with Apatinib conversion therapy was 1 year).

Drug: adbelimumab; Procedure: SBRT; Drug: apatinib

Interventions

adbelimumab DRUG

adbelimumab：1200mg iv d1 q3w

Conversion queue; Perioperative queue

SBRT PROCEDURE

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

Conversion queue; Perioperative queue

apatinib DRUG

apatinib：250mg po, qd

Conversion queue; Perioperative queue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard
• ECOG performance status of 0 or 1
• Life expectancy ≥ 12 weeks
• Subjects are diagnosed with resectable stage IB- IIIA HCC cancer.
• The main organ's function is normal and it should meet the following criteria(Excludes use of any blood components and cell growth factors during the screening period)
• Absolute neutrophil count≥1.5×109 /L
• Platelets≥75×109/L ;Hemoglobin≥9.0 g/dL; Serum albumin≥3g/dL
• Thyroid stimulating hormone (TSH)≤1.0×upper limit of normal(ULN)（If abnormal, T3 and T4 levels should be examined at the same time）
• Total bilirubin (TBIL)≤1.5×upper limit of normal (ULN); ALT and AST≤1.5×upper limit of normal(ULN); AKP≤ 2.5×upper limit of normal(ULN)
• Serum creatinine ≤1.5×ULN or creatinine clearance \> 60 mL/minute (using Cockcroft-Gault formula)

You may not qualify if:

• 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.
• Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment.
• Known genetic or acquired hemorrhage or thrombotic tendency.
• Thrombosis or thromboembolic event within 6 months prior to the start of study treatment.
• Cardiac clinical symptom or disease that is not well controlled.
• Subjects have uncontrollable hypertension (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg), despite patients have taken the best drug treatment ；Subjects have had a hypertensive crisis or hypertensive encephalopathy
• Patient develops severe vascular disease within 6 months before the start of study treatment.
• Patients with severe, unhealed or split wounds and active ulcers or untreated fractures.
• Patients who underwent surgical treatment within 4 weeks prior to the start of study treatment.
• Factors to affect oral administration (such as patients unable to swallow oral medications, malabsorption syndrome etc. situations evidently affect drug absorption).
• Patients with gastrointestinal diseases such as intestinal obstruction (including incomplete intestinal obstruction) or those who may have caused gastrointestinal bleeding, perforation or obstruction.
• There is evidence of intragastric gas that cannot be explained by puncture or recent surgery.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Jingfeng Liu, DR

CONTACT

13905029580; drjingfeng@126.com

Yu Chen, DR

CONTACT

13859089836; chenyu1980@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 6, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 6, 2024

Record last verified: 2024-07