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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyperbaric oxygen therapy plus Camrelizumab | Combination Product | Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response Rate per RECIST v1.1 | time from the date of CR or PR until PD | up to 12 months |
| Disease control rate per RECIST v1.1 | Disease control rate (DCR)=CR + PR + stable disease |
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Inclusion Criteria:
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:
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:
Exclusion Criteria:
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:
Active HCV infected subjects (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);
Live vaccine was administered within 30 days before the first administration (cycle 1, day 1);Note: it is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before the first administration; However, live attenuated influenza vaccines administered intranasal are not allowed.
Female subjects who are pregnant, breastfeeding or refuse contraception.
Subjects have any serious or uncontrollable systemic diseases, such as:
Subjects are unsuitable for participation in this research after comprehensive assessment by the researchers.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ze-yang Ding, M.D. | Contact | +86-13407156200 | dingzyang@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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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.
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| up to 12 months |
| Overall Survival | Duration from the date of initial treatment with hyperbaric oxygen therapy plus Camrelizumab to the date of death due to any cause. | up to 12 months |
| Number of Subjects with one or more adverse events as assessed by CTCAE 5.0 | Safety and tolerability of hyperbaric oxygen therapy plus Camrelizumab as assessed by the frequency, duration, and severity of adverse events | From screening through 30-35 days after end of treatment, up to 12 months |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| C000631724 | camrelizumab |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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