Hyperbaric Oxygen Therapy Combined Camrelizumab in Patients With Advanced/Metastatic Hepatocellular Carcinoma

Sponsor
Zhang Bi Xiang, MD
Study ID
NCT05031949
Phase
PHASE1
Status
Unknown

Conditions

  • Combinational Immunotherapy
  • Hepatocellular Carcinoma Non-Resectable
  • Hyperbaric Oxygen Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to explore the efficacy and safety of hyperbaric oxygen therapy plus Camrelizumab as a second-line treatment in patients with advanced hepatocellular carcinoma who have failed at least 1 previous treatment.

Key Dates

Start date
Oct 30, 2021
Status verified
Dec 2023
Primary completion
Dec 31, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Hyperbaric oxygen therapy plus Camrelizumab
    Subjects receive Camrelizumab intravenous at the dose 3mg/kg on Day 1 every 3 weeks, and breath pressurized (0.25 MPa) 100% oxygen (O2) indirectly by a head hood or mask for 60 minutes in multiplace chambers at Day 1 of every week.

Primary Outcome Measure

Objective Response Rate (ORR) per RECIST v1.1 [ Time Frame: up to 12 months. ]

Central Contacts

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