RFA Plus Carrizumab vs Carrizumab Alone for HCC

NCT04150744 | Recruiting Phase 2

• 1 other identifier: 1102320191018
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS.

Conditions

Tumor Immunity; Immunosuppression; Radiofrequency Ablation

Keywords

RFA; immunosuppressant; hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Time from patients received treatment fist time to disease progress or death

  through study completion, an average of 4 years

Secondary Outcomes (4)

• Objective response rate

  through study completion, an average of 4 years

• Disease control rate

  through study completion, an average of 4 years

• Overall survival

  through study completion, an average of 4 years

• Duration of response

  through study completion, an average of 4 years

Study Arms (2)

RFA plus carrizumab

EXPERIMENTAL

Combination Product: radiofrequency ablation

carrizumab

PLACEBO COMPARATOR

Combination Product: radiofrequency ablation

Interventions

radiofrequency ablation COMBINATION_PRODUCT

take advantage of RFA to destroy hepatocellular carcinoma by high temperature

RFA plus carrizumab; carrizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18-75 years
• Diagnosis as hepatocellular carcinoma from histology and cytology
• BCLC B-C degree
• Score of ECOG PS: 0-2
• Child-Pugh Score: A or B
• Not suitable for resection or liver transplantation
• Have not received systemic therapy
• Have at least one evaluable target mass from CT or MRI according to mRECIST
• The estimated survival time ≥ 12 weeks
• Patients with HBV infection having HBV-DNA \<500IU/mL and standard anti-virus treatment. Patients with HCV infection must receive standard anti-virus treatment.
• The function of main organs normal
• Sign informed consent

You may not qualify if:

• Have cholangiocarcinoma, mixed type of hepatocarcinoma and fibrolamellar hepatocellular carcinoma. Have incurable malignant tumor in five years.
• Have local ablation, TACE or radiotherapy in 3 months before enrolled.
• Prepared to or have received organic or bone marrow transplantation.
• Uncontrollable ascites, hepatic encephalopathy or esophageal and gastric varices.
• Have hypertension and can't lower down to the normal level using blood pressure medication.
• Have type II myocardial ischemia or myocardial infarction, uncontrollable arrhythmia.
• Have diseases to influent the effect of oral drugs, for example, unable to swallow, chronic diarrhea and intestinal obstruction.
• Have gastrointestinal bleeding in 6 months
• Have abdominal fistula, gastrointestinal perforation or abdominal abscess
• Patients with lung fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug related pneumonia or severe dysfunction of lung.
• Routine urine test showed urinary protein ≥++ or the 24 hours amount of urinary protein ≥1.0 g
• Patients have autoimmune disease
• Patients need corticosteroid or other immunosuppressant therapy
• Patients have anti-tumor vaccine and other immunostimulate anti-tumor drugs in 3 months
• Allergy to monocloning antibody

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiofrequency Ablation

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Zhe Tang, Dr.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Tang, Dr.

CONTACT

13757118212; 8xi@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 5, 2019
• Study Start: August 1, 2020
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 8, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)