NCT04974281UnknownPhase 1
Efficacy and Safety of PD-1 Antibody and Lenvatinib Plus TACE on Downstaging Hepatocellular Carcinoma With BCLC B/C
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Fudan University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Resection rate
Study Overview
Brief Summary
The purpose of this study is to assess the difference of safety and efficacy about PD-1 Antibody and Lenvatinib Plus transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma with BCLC B/C.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years old and ≤75 years old;
- •Clinically diagnosed as hepatocellular carcinoma, stage B/C of BCLC;
- •No history of severe arrhythmia or heart failure;
- •No history of severe ventilation dysfunction or severe pulmonary infection;
- •No acute or chronic renal failure, the creatinine clearance rate was >40 mL/min;
- •Liver function Child A;
- •Blood routine: absolute neutrophils count ≥1.5×10^9/L, Hb≥8.5g/L, PLT≥75×10^9/L;
- •Coagulation function: INR≤2.3;
- •ECOG score <2;
- •No local or systemic treatment, such as TACE, RFA, targeted drugs, traditional Chinese medicine, etc., before enrollment;
- •Expected survival ≥12 weeks;
- •At least one lesion can be measured and evaluated by CT/MRI according to RECIST 1.1 criteria;
- •Understand and sign the informed consent.
Exclusion Criteria
- •Pregnant or lactating women;
- •Patients with other malignant tumors;
- •patients with complicated mental illness;
- •patients who have participated in other clinical trials in the last three months;
- •known or suspected allergy to any drug related to the study;
- •Patients with positive immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
- •Patients treated with other targeted drugs, PD-L1 antibody and other immunotherapy or FOLFOX systemic chemotherapy after inclusion;
- •Patients with ≥1 + proteinuria indicated by urine routine will receive 24-hour urine protein detection, and patients with ≥1g 24-hour urine protein will not be included in the group.
- •Active autoimmune diseases that require systemic treatment (use of disease-alleviating agents, such as corticosteroids or immunosuppressants)
- •Patients with uncontrolled hepatitis B/C infection
- •Other conditions that the researcher considers not suitable for inclusion in this study
Arms & Interventions
PD-1+TACE+Len
Other
PD-1 Antibody and Lenvatinib Plus TACE
Intervention: PD-1 and Lenvatinib Plus TACE (Combination Product)
Outcomes
Primary Outcomes
Resection rate
Time Frame: 6 months after downstaging treatment
Resction rate refers to the proportion of patients who can receive radical surgery after downstaging treatment.
Secondary Outcomes
- Adverse events (safety)(6 months)
- Objective response rate (ORR)(6 months)
- Overall survival (OS)(2 years)
- Progression free survival (PFS)(6 months)
Investigators
Lunxiu Qin
Director, Clinical Professor
Fudan University
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Not Applicable
Efficacy and Safety of Neoantigen Peptide Vaccine in the Treatment of Advanced NSCLC Progressed After EGFR-TKI TreatmentEGFR Gene MutationNSCLCNCT06095934The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School20
Recruiting
Phase 1
Anti-PD-1 Antibody Alone or in Combination With Decitabine/Chemotherapy in Relapsed or Refractory MalignanciesMalignancies MultipleNCT02961101Han weidong250
Recruiting
Phase 2
Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT06259721Jiangxi Provincial Cancer Hospital22
Recruiting
Phase 2
Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell LymphomaRelapsed/Refractory Peripheral T-cell LymphomaNCT05182957The First Affiliated Hospital of Soochow University31
Not yet recruiting
Phase 2
Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Esophagogastric Junction AdenocarcinomaAdenocarcinoma of Esophagogastric JunctionNCT05505461Peking University People's Hospital26