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

NCT05031949 | Unknown Phase 1 DMC

• 1 other identifier: 2021-S087
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

hyperbaric oxygen therapy; Camrelizumab; hepatocellular carcinoma; second-line treatment

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) per RECIST v1.1

  ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (≥ 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1.

  up to 12 months.

• Progression-free survival based on RECIST v1.1

  Progression-free survival defined as the time from the first day of taking study drug to death or disease progression by RECIST v1.1.

  Time from first treatment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcomes (4)

• Duration of Response Rate per RECIST v1.1

  up to 12 months

• Disease control rate per RECIST v1.1

  up to 12 months

• Overall Survival

  up to 12 months

• Number of Subjects with one or more adverse events as assessed by CTCAE 5.0

  From screening through 30-35 days after end of treatment, up to 12 months

Study Arms (1)

Hyperbaric oxygen therapy plus Camrelizumab

EXPERIMENTAL

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.

Combination Product: hyperbaric oxygen therapy plus Camrelizumab

Interventions

hyperbaric oxygen therapy plus Camrelizumab COMBINATION_PRODUCT

Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody

Hyperbaric oxygen therapy plus Camrelizumab

Eligibility Criteria

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

You may qualify if:

• Subjects volunteer to participate in the study and agree to sign the informed consent with good compliance and follow-up.
• Subjects are 18 years old or older when signing the informed consent and gender is not limited.
• Histologically confirmed HCC in advanced stage; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.1
• Failed or intolerable to at least one prior systemic treatment for advanced HCC
• With at least one assessment lesion according to the RESIST v1.1 criteria.
• Estimated survival time ≥ 12 weeks.
• The ECOG score is 0-1 within 1 week before enrollment.
• Adequate organ function, including:
• Whole blood cell examination (no blood transfusion within 14 days, no G-CSF use and no drugs use): Hb≥90g/L, ANC≥1.5×10\*9/L, PLT≥70×10\*9/L;
• Biochemical examination (no ALB infused within 14 days): ALB≥29 g/L, ALT and AST\<5×ULN, TBIL≤1.5×ULN, creatinine≤1.5×ULN, and prothrombin time or INR ≤1.5×ULN;
• thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
• Without biliary obstruction. Subjects who need biliary stent implantation must be completed at least 7 days before enrollment
• Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 60 days for female subjects and 120 days for male subjects after the last dose of study drug
• Subjects with asymptomatic or stable brain metastases after local treatment are allowed to be included as long as they meet the following conditions:
• measurable lesions outside the central nervous system;

You may not qualify if:

• Subjects with one or more than one of the following criteria should be excluded
• Subjects has contraindications of hyperbaric oxygen use, including pneumothorax, mediastinal edema, multiple rib fractures, open trauma of chest wall, vacuolar pulmonary tuberculosis with hemoptysis, pulmonary bullae, active internal bleeding and hemorrhagic diseases;
• Subjects with other malignant tumors in the past 5 years (radical skin basal cell carcinoma, skin squamous epithelial carcinoma, and / or radical resection of carcinoma in situ were not included);
• subjects are currently participating in other interventional clinical studies, or received any topical treatment within 4 weeks prior to the study, including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection;
• systemic treatment with traditional Chinese medicine with anti-tumor indications or drugs with immunomodulatory effect (including thymosin, interferon and interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration;
• Diagnosis of immunodeficiency or systemic steroid therapy or any form of immunosuppressants therapy within 7 days prior to this study. A physiological dose of corticosteroids (no more than 7.5 mg/d prednisone or equivalent) can be approved after clinical evaluation;
• Pleural effusion or Ascites with clinical symptoms which requires pleural or abdominal puncture or drainage therapy;
• Subjects have organ transplantation history.
• Subjects are allergic to the active ingredients or excipients of Camrelizumab;
• Subjects with multiple factors affecting oral drugs (such as inability to swallow, post gastrointestinal resection, chronic diarrhea and intestinal obstruction);
• Not fully recovered from toxicity and / or complications caused by any intervention before starting treatment (i.e. ≤ grade 1 or reaching baseline, excluding fatigue or hair loss);
• Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1 / 2 antibody positive);
• Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number at the same time was higher than the upper limit of normal value in the laboratory of the research center).Note: hepatitis B patients who meet the following criteria can also be enrolled:
• Before the first administration, the HBV viral load was less than 1000 copies / ml (200 IU / ml). Subjects should receive anti HBV treatment throughout the study chemotherapy treatment to avoid virus reactivation;
• For subjects with anti HBC (+), HBsAg (-), anti HBS (-) and HBV viral load (-), preventive anti HBV treatment is not required, but virus reactivation needs to be closely monitored.

Sponsors & Collaborators

• Zhang Bi Xiang, MD: lead

Study Sites (1)

Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hyperbaric Oxygenation; camrelizumab

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)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Central Study Contacts

Ze-yang Ding, M.D.

CONTACT

+86-13407156200; dingzyang@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.; M. D.; Ph. D.

Model Details: A Phase 1b, Open-Label, Single-Arm Study 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.

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 2, 2021
• Study Start: October 30, 2021
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

CN (1)