Multicenter, Single-Arm, Prospective Phase II Study of Neoadjuvant Cryo-Thermal Ablation Combined With Toripalimab and Chemotherapy for Resectable Stage IB-IIIB Non-Small Cell Lung Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Neoadjuvant chemoimmunotherapy has improved outcomes in patients with resectable non-small cell lung cancer (NSCLC), but a substantial proportion of patients do not achieve a major pathological response. Cryo-Thermal Ablation may induce immunogenic tumor cell death and remodel the tumor immune microenvironment, potentially enhancing the antitumor activity of subsequent chemoimmunotherapy. This multicenter, single-arm, open-label, prospective Phase II study will evaluate the efficacy and safety of CT-guided Cryo-Thermal Ablation followed by toripalimab plus platinum-based doublet chemotherapy as neoadjuvant treatment for patients with resectable stage IB-IIIB NSCLC. For stage IB disease, only patients with cT2aN0M0 disease and a maximum primary tumor diameter of 4.0 cm are eligible. Patients with more advanced disease must be considered resectable by multidisciplinary team assessment according to the study protocol. Approximately 40 participants will receive Cryo-Thermal Ablation followed by 3 planned cycles of toripalimab plus platinum-based doublet chemotherapy and subsequent curative-intent surgical resection. The primary outcome is the pathological complete response (pCR) rate. Secondary outcomes include major pathological response (MPR) rate, objective response rate (ORR), R0 resection rate, event-free survival (EFS), overall survival (OS), treatment-emergent adverse events (TEAEs), and health-related quality of life. Exploratory translational analyses will investigate treatment-associated local and systemic antitumor immune responses and molecular dynamics using spatial transcriptomics, T-cell receptor sequencing, tumor genomic profiling, circulating tumor DNA analysis, imaging mass cytometry, and exploratory intratumoral metagenomic and metabolomic profiling.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Rak płuca potwierdzony badaniem histologicznym lub cytologicznym.
- •Choroba w stadium od IB do IIIB, która według lekarzy kwalifikuje się do operacji.
- •Pacjenci w stadium IB muszą mieć guz o maksymalnej średnicy 4 cm.
- •Choroba musi nadawać się do pobrania próbki przezskórnej i zabiegu wymrażania/ogrzewania pod kontrolą tomografii komputerowej.
- •Pacjenci w wieku od 18 do 80 lat.
- •Ogólny stan zdrowia dobry, pozwalający na pełne uczestnictwo w badaniu i planowane leczenie.
✗ Disqualifies
- •Pacjenci, którzy wcześniej otrzymali jakiekolwiek leczenie raka płuca.
- •Pacjenci z chorobami, które znacząco wpływają na czynność płuc lub ogólny stan zdrowia.
- •Pacjenci z innymi poważnymi chorobami współistniejącymi, które mogłyby stanowić przeciwwskazanie do leczenia.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Last updated (source)
- October 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (9)
The Third People's Hospital of Chengdu
Chengdu, China
Sichuan Cancer Hospital & Institute
Chengdu, China
West China Hospital, Sichuan University
Chengdu, China
Public Health Clinical Center of Chengdu
Chengdu, China
The Affiliated Hospital of Southwest Medical University
Luzhou, China
Meishan People's Hospital
Meishan, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, China
Suining Central Hospital
Suining, China
Zigong Fourth People's Hospital
Zigong, China
Trial contact
Beinuo Wang, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/3/2026.
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