Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Cholangiocarcinoma

Liver Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Bile Duct Cancer

Primary Liver Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antibodies

Antibodies, Monoclonal

Lenvatinib

Angiogenesis Inhibitors

Immunoglobulins

Endothelial Growth Factors

Mitogens

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Lenvatinib is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT.

Pembrolizumab is a recombinant anti-human PD-1 monoclonal antibody.

Lenvatinib 12mg, once a day, oral at least 38 days of each 6 weeks cycle. Pembrolizumab 200mg, every 3 weeks, intravenous infused of each 6 weeks cycle. Number of cycle: until progression or unacceptable toxicity develops.

Lenvatinib plus Pembrolizumab

Haitao Zhao, Prof

The investigators design a phase IIB clinical study to explore the efficacy and safety of lenvatinib plus pembrolizumab as a second-line treatment in patients with advanced hepatobiliary malignant tumors and to analyze potential biomarkers of therapeutic response.

This trial is a single-arm, non-randomized and single-center clinical study of targeted therapy combined immunotherapy in patients with hepatobiliary malignant tumors.

It is estimated that 50 patients who met the study criteria will be enrolled in PUMCH and treated with lenvatinib and pembrolizumab. The investigators will follow up and collect subjects' data each month to evaluate the efficacy and safety of treatment, including overall survival and time to progression. Multi-omics data analysis will be used to find potential biomarkers of treatment response.

Patients were confirmed with advanced hepatobiliary malignancies by imaging and histological examination and meet with the inclusive criteria, including hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, gallbladder carcinoma, and mixed cancer)

Lenvatinib Combined Pembrolizumab in Advanced Hepatobiliary Tumors

Lenvatinib Combined Pembrolizumab as a Second-line Treatment in Advanced Hepatobiliary Tumors: a Single-center, Single-arm, Non-randomized Clinical Study

Any adverse events related with treatment with lenvatinib plus pembrolizumab.

Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.

Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.

A duration from the date of initial treatment with lenvatinib plus pembrolizumab to disease progression (defined by RECIST 1.1) or death of any cause.

Duration from the date of initial treatment with lenvatinib plus pembrolizumab to the date of death due to any cause.

Duration from the first time reported partial response or complete response to the first time of disease progression or death.

Proportion of patients with stable disease status more than 4 months.

Peking Union Medical College Hospital

Carcinoma, Hepatocellular

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.

Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody

hyperbaric oxygen therapy plus Camrelizumab

Ze-yang Ding, M.D.

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.

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.

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

A Single-center, Single-arm, Non-randomized Clinical Study to Evaluate the Efficacy and Safety of Hyperbaric Oxygen Therapy Plus Camrelizumab as a Second-line Treatment in Advanced/Metastatic Hepatocellular Carcinoma

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.

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

Disease control rate (DCR)=CR + PR + stable disease

Duration from the date of initial treatment with hyperbaric oxygen therapy plus Camrelizumab to the date of death due to any cause.

Safety and tolerability of hyperbaric oxygen therapy plus Camrelizumab as assessed by the frequency, duration, and severity of adverse events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lenvatinib Combined Pembrolizumab in Advanced Hepatobiliary Tumors	NCT03895970	Liver Neoplasm ... Cholangiocarcin... Combinational I... Biomarker	Lenvatinib plus...	18 Years -	Peking Union Medical College Hospital
Hyperbaric Oxygen Therapy Combined Camrelizumab in Patients With Advanced/Metastatic Hepatocellular Carcinoma	NCT05031949	Combinational I... Hepatocellular ... Hyperbaric Oxyg...	hyperbaric oxyg...	18 Years -	Tongji Hospital
Hyperbaric Oxygen Therapy Combined Camrelizumab in Patients With Advanced/Metastatic Hepatocellular Carcinoma	NCT05031949	Combinational I... Hepatocellular ... Hyperbaric Oxyg...	hyperbaric oxyg...	18 Years -	Tongji Hospital

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