Hyperbaric Oxygen Therapy Combined Camrelizumab in Patients With Advanced/Metastatic Hepatocellul… (NCT05031949) | Clinical Trial Compass
UnknownPhase 1
Hyperbaric Oxygen Therapy Combined Camrelizumab in Patients With Advanced/Metastatic Hepatocellular Carcinoma
China20 participantsStarted 2021-10-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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:
Exclusion criteria
✕. 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;
What they're measuring
1
Objective Response Rate (ORR) per RECIST v1.1
Timeframe: up to 12 months.
2
Progression-free survival based on RECIST v1.1
Timeframe: 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
✕. 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;