A Phase II Study to Evaluate the Efficacy and Safety of Cryoablation Combined With Tislelizumab Plus Lenvatinib in Previously Treated Gastric Cancer Liver Metastasis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Tislelizumab plus Lenvatinib for patients with gastric cancer liver metastasis in the second-/third-Line setting.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Written informed consent obtained.

• Age ≥ 18 years at time of study entry.

• Participants must have gastric cancer liver metastasis.

• Participants must have failed at least one previous systemic chemotherapy regimens in the liver metastatic setting.

• Participants who had received previous anti-angiogenesis or anti-PD1/PDL1 therapy were eligible.

• At least one measurable site of disease as defined by RECIST v1.1 with spiral CT scan or MRI.

• Performance status (PS) ≤ 2 (ECOG scale).

• Life expectancy of at least 12 weeks.

• Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥75 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula )

• Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.

• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Peng Wang, MD
wangp413@163.com
86-21-64175590
Time Frame
Start Date: 2023-06-16
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 25
Treatments
Experimental: Cryoablation combined with Tislelizumab and lenvatinib
Cryoablation treatment starts at day 0. Tislelizumab and Lenvatinib will be initiated on day 14 after cryoablation. Tislelizumab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov