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Cryoablation with or Without Serplulimab in Treating Patients with Stage I-IIA Non-small Cell Lung Cancer

NCT06580665 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-08-30

No results posted yet for this study

Summary

Cryoablation is a minimally invasive technique that utilizes very low temperature to eliminate tumour cells for patients ineligible for surgery. It has been reported that cryoablation may enhance immune response and synergize with immunotherapy.

This study is a multicenter, randomized, controlled, exploratory trial, and is expected to enroll a total of 134 patients. The enrolled patients were stage Ia, Ib, or IIa lung cancer with negative driver gene mutations, who are considered high-risk for surgery or refuse surgery based on multidisciplinary evaluation. Eligible patients will be randomly assigned in a 1:1 ratio to receive either cryoablation alone (CA group) or cryoablation combined with immunotherapy (I-CA group). The study aims to evaluate the safety and clinical benefits of combining immunotherapy with cryoablation in the treatment of early-stage NSCLC by comparing progression-free survival (PFS), objective response rate (ORR), overall survival (OS), and the incidence of adverse events between the two groups.

Conditions

Interventions

PROCEDURE

Cryoablation

Patients undergo cryoablation.

DRUG

Serplulimab

Patients undergo cryoablation. If there are no significant postoperative complications, Serplulimab should be administered immediately. Cycles with Serplulimab repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • Shanghai Henlius Biotech Co., Ltd.

    collaborator UNKNOWN

  • AccuTarget MediPharma (Shanghai) Co., Ltd

    collaborator UNKNOWN

  • Shanghai Chest Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2028-09-01
Completion
2030-08-11

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06580665 on ClinicalTrials.gov