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

NCT06580665 | Not Yet Recruiting

• 1 other identifier: IS24040
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 5

Brief 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

Non-small Cell Lung Cancer

Keywords

Cryoablation; Serplulimab; Early non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• 3-year progression-free survival (PFS)

  This refers to the length of time between the participant's first onset of disease progression or death from any cause after treatment.

  3 years

Secondary Outcomes (4)

• 1-year, 2-year, and 3-year Objective Response Rate (ORR)

  3 years

• Overall Survival (OS)

  5 years

• Incidence of Adverse Events

  1 year

• Potential Predictive and Immunological Biomarkers (lymphocyte phenotypes, PD-L1 expression, cytokines)

  1 year

Study Arms (2)

Cryoablation alone (CA group)

EXPERIMENTAL

Patients undergo cryoablation alone.

Procedure: Cryoablation

Cryoablation combined with immunotherapy (I-CA group)

EXPERIMENTAL

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.

Procedure: Cryoablation; Drug: Serplulimab

Interventions

Cryoablation PROCEDURE

Patients undergo cryoablation.

Cryoablation alone (CA group); Cryoablation combined with immunotherapy (I-CA group)

Serplulimab DRUG

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.

Cryoablation combined with immunotherapy (I-CA group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically diagnosed as primary peripheral non-small cell lung cancer, preoperative staging suggested stage Ia, Ib, or IIa (size≤5 cm, T1-T2N0M0), according to the 9th edition of the TNM classification for lung cancer;
• Negative driver gene mutation: driver genes were defined as EGFR, ALK, etc;
• Age ≥18 years old;
• The ECOG PS score is 0-2;
• Expected survival ≥3 months;
• Patients who are considered high-risk for surgery/radiotherapy or refuse surgery/radiotherapy based on multidisciplinary evaluation;
• Patients who have not received previous immunotherapy with PD-1, PD-L1 or CTLA-4 antibodies;
• All patients must agree to receive cryoablation (with or without Serplulimab) as an initial therapy and sign a study-specific consent form.

You may not qualify if:

• Patients with poor cardiopulmonary function or other comorbidities who cannot tolerate multimode thermal therapy;
• Patients whose chest CT indicated that the lung lesions could not be reached percutaneously or transbronchially;
• Severe liver and kidney function and coagulation function abnormalities, platelet count \<70×109/L;
• Patients who have received other anti-tumor drugs in the past 6 months or have used immune checkpoint inhibitors before;
• The patient has an uncontrolled disease (including but not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia, mental illness, etc.);
• Primary immune deficiency or autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.);
• Pregnant and lactating women;
• Long-term use of steroid;
• Other circumstances considered inappropriate for participation in this study.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Shanghai Henlius Biotech Co., Ltd.: collaborator
• AccuTarget MediPharma (Shanghai) Co., Ltd: collaborator

Study Sites (5)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Jiayuan Sun

CONTACT

+86-021-22200000; jysun1976@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 30, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): August 11, 2030
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)