Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant and Adjuvant Therapy in Resectable Stage II-IIIB NSCLC

NCT ID: NCT06939127

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-05-31

Brief Summary

This is a Phase II single-arm study designed to evaluate the efficacy and safety of cryoablation combined with tislelizumab and platinum-based doublet chemotherapy as neoadjuvant therapy, followed by adjuvant tislelizumab therapy in patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC).

The study consists of a screening phase, a treatment phase (including the neoadjuvant stage, surgery, and adjuvant stage), a safety follow-up period, and a survival follow-up period.

Conditions

NSCLC (Non-small Cell Lung Cancer)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cryoablation Combined with Tislelizumab

Neoadjuvant Phase:

Eligible patients first undergo cryoablation of the primary tumor. Then, 7±3 days after cryoablation, they start treatment with tislelizumab (200 mg) plus platinum-based doublet chemotherapy, given every 3 weeks for 3-4 cycles.

Surgery should be performed as soon as possible within 4-6 weeks after the last dose of neoadjuvant therapy.

Adjuvant Phase:

The first dose of tislelizumab (cycle 1 of the adjuvant phase) should be administered within 2-8 weeks after surgery. Patients will continue to receive tislelizumab (400 mg, Q6W) as adjuvant therapy every 6 weeks until one of the following events occurs: completion of 8 cycles of tislelizumab adjuvant therapy, disease recurrence, unacceptable adverse events (AEs), death, or decision by the patient and/or investigator to discontinue study treatment.

Group Type: EXPERIMENTAL

Neoadjuvant Cryoablation Combined with Tislelizumab and Chemotherapy

Intervention Type: DRUG

Eligible patients will start the study treatment (7-14 days between pathological diagnosis and cryoablation). Patients first undergo cryoablation of the primary tumor. Then, 7±3 days after cryoablation, they start treatment with tislelizumab (200 mg) plus platinum-based doublet chemotherapy, given every 3 weeks for 3-4 cycles.

The following platinum-based doublet chemotherapy regimens are allowed in this trial:

• Cisplatin/carboplatin + pemetrexed (non-squamous NSCLC)
• Cisplatin/carboplatin + albumin-bound paclitaxel/paclitaxel (squamous NSCLC)

Surgery

Intervention Type: PROCEDURE

After completing neoadjuvant therapy, surgery should be performed as soon as possible within 4-6 weeks after the last dose of neoadjuvant therapy.

Adjuvant tislelizumab

Intervention Type: DRUG

Patients receiving adjuvant therapy must meet the following criteria:

• ECOG performance status score of 0 or 1
• Recovery from surgery and adequate organ function as determined by the investigator based on laboratory values During the adjuvant phase, patients will receive tislelizumab as adjuvant therapy. The first dose of tislelizumab (cycle 1 of the adjuvant phase) should be administered within 2-8 weeks after surgery. Patients will continue to receive tislelizumab (400 mg, Q6W) as adjuvant therapy every 6 weeks until one of the following events occurs: completion of 8 cycles of tislelizumab adjuvant therapy, disease recurrence, unacceptable adverse events (AEs), death, or decision by the patient and/or investigator to discontinue study treatment.

Interventions

Neoadjuvant Cryoablation Combined with Tislelizumab and Chemotherapy

Eligible patients will start the study treatment (7-14 days between pathological diagnosis and cryoablation). Patients first undergo cryoablation of the primary tumor. Then, 7±3 days after cryoablation, they start treatment with tislelizumab (200 mg) plus platinum-based doublet chemotherapy, given every 3 weeks for 3-4 cycles.

The following platinum-based doublet chemotherapy regimens are allowed in this trial:

• Cisplatin/carboplatin + pemetrexed (non-squamous NSCLC)
• Cisplatin/carboplatin + albumin-bound paclitaxel/paclitaxel (squamous NSCLC)

Intervention Type: DRUG

Surgery

After completing neoadjuvant therapy, surgery should be performed as soon as possible within 4-6 weeks after the last dose of neoadjuvant therapy.

Intervention Type: PROCEDURE

Adjuvant tislelizumab

Patients receiving adjuvant therapy must meet the following criteria:

• ECOG performance status score of 0 or 1
• Recovery from surgery and adequate organ function as determined by the investigator based on laboratory values During the adjuvant phase, patients will receive tislelizumab as adjuvant therapy. The first dose of tislelizumab (cycle 1 of the adjuvant phase) should be administered within 2-8 weeks after surgery. Patients will continue to receive tislelizumab (400 mg, Q6W) as adjuvant therapy every 6 weeks until one of the following events occurs: completion of 8 cycles of tislelizumab adjuvant therapy, disease recurrence, unacceptable adverse events (AEs), death, or decision by the patient and/or investigator to discontinue study treatment.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged ≥18 years at informed consent signing.
• ECOG performance status of 0 or 1.
• Histologically confirmed stage II-IIIB NSCLC (AJCC 9th edition).
• Tumor size ≤5 cm.
• Deemed suitable for R0 resection by a thoracic surgeon for radical treatment.
• Adequate cardiopulmonary function for radical surgical resection.
• Eligible for cryoablation and platinum-based doublet chemotherapy.
• Adequate blood and organ function, as per laboratory tests within 14 days before enrollment.

Exclusion Criteria

• Prior treatment for current lung cancer, including chemotherapy or radiotherapy.
• LCNEC diagnosis.
• Known EGFR mutations or ALK translocations. For non-squamous NSCLC, EGFR mutation status must be confirmed locally or centrally if unknown.

For squamous NSCLC, EGFR testing is not required if status is unknown. ALK translocation testing is not required if status is unknown.

• Locally advanced, unresectable disease, regardless of stage or metastasis (stage IV). Patients with mediastinal lymph node involvement on CT must undergo sampling for clinical staging to exclude stage IIIB/C.
• History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled pulmonary fibrosis.
• Severe chronic or active infections requiring systemic antimicrobials, including tuberculosis.
• Hospitalization for severe infections within 4 weeks before enrollment. Systemic antibiotic treatment within 2 weeks before enrollment.
• Active autoimmune disease or history of recurrent autoimmune disease.
• Exceptions: Well-controlled type 1 diabetes, hypothyroidism on hormone replacement, celiac disease, skin conditions not requiring systemic therapy, or diseases unlikely to recur without provocation.
• Severe infections requiring systemic treatment within the past 4 weeks.
• Corticosteroid or immunosuppressive use within 14 days before enrollment, except for specific local, topical, or short-term uses.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dongsheng Yue

Chief Physician of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dongsheng Yue Chief Physician of Surgery

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Donsheng Yue Chief Physician of Surgery

Role: CONTACT

yuedongsheng_cg@163.com

+8602223109106

Facility Contacts

Dongsheng Yue Chief Physician of Surgery

Role: primary

yuedongsheng_cg@163.com

+8602223109106

Other Identifiers

CONCEPT study

Identifier Type: -

Identifier Source: org_study_id