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Not yet recruitingNCT07729670Updated Jul 27, 2026

Multimodal Ablation Combined With Perioperative Tislelizumab and Chemotherapy for Resectable II-IIIB NSCLC

A Phase 2 interventional study of Multimodal Ablation and Neoadjuvant therapy in NSCLC, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a prospective, open-label, single-center, single-arm phase II clinical trial evaluating the efficacy and safety of multimodal ablation in combination with perioperative tislelizumab and chemotherapy in patients with pathologically confirmed resectable stage II-IIIB (N2) non-small cell lung cancer (NSCLC).

Read the detailed description

Eligible patients will receive multimodal ablation, followed by perioperative tislelizumab in combination with platinum-based doublet chemotherapy, and subsequently undergo radical surgical resection. Adjuvant tislelizumab will be continued after surgery.The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, event-free survival (EFS), overall survival (OS), and safety.

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Conditions studied

  • NSCLC
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In context

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age >= 18 years, either gender;
  • Pathologically confirmed stage II-IIIB (N2) squamous or non-squamous non-small cell lung cancer (NSCLC) according to the 9th edition of the AJCC/UICC NSCLC staging system;
  • Presence of lesions suitable for ablation therapy confirmed by imaging evaluation;
  • Evaluated as resectable with R0 resection before enrollment, and consent to undergo radical surgical resection;
  • ECOG performance status score of 0-1;
  • Eligible for platinum-based doublet chemotherapy;
  • Adequate cardiopulmonary function to meet the requirements of curative surgical resection;
  • Sufficient organ function confirmed by laboratory tests within 28 days before enrollment:

    • Blood routine: WBC >= 3.0×10\^9/L; ANC >= 1.5×10\^9/L; PLT >= 100×10\^9/L; HGB >= 90 g/L.
    • Liver function: AST \<= 5.0×ULN; ALT \<= 5.0×ULN; TBIL \<= 1.5×ULN;
    • Renal function: Cr \<= 1.5×ULN;
    • For patients receiving cisplatin: creatinine clearance >= 60 mL/min.
    • For patients receiving carboplatin: creatinine clearance >= 45 mL/min.
    • Coagulation function: INR \<= 1.5×ULN (\<=3×ULN for patients on anticoagulants; anticoagulants must be discontinued for one week before ablation); APTT \<= 1.5×ULN;
  • Fully understand the study and voluntarily sign the informed consent form (ICF).

Exclusion criteria

Exclusion Criteria:

  • Tumor is adjacent to the hilum, invades major blood vessels, or has contraindications for surgery;
  • History of interstitial lung disease, non-infectious pneumonia, or uncontrolled pulmonary diseases including pulmonary fibrosis and acute lung disease;
  • Previous allogeneic stem cell transplantation or organ transplantation;
  • Previous radiotherapy or chemotherapy;
  • Previous local treatment (e.g., radioactive seed implantation, ablation) for the target ablation lesion;
  • Previous treatment with immune checkpoint inhibitors, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies;
  • Complicated with severe cardiac, pulmonary, hepatic, renal insufficiency, or coagulation disorders;
  • Clinically significant cardio-cerebrovascular diseases, including but not limited to acute myocardial infarction within 6 months before enrollment, heart failure of NYHA class III or IV, ventricular arrhythmia ≥ grade 2, any history of cerebrovascular accident;
  • Underwent any major surgical procedure requiring general anesthesia within 28 days before enrollment;
  • Previous severe immune system diseases or active infection;
  • Pregnant or lactating female;
  • Complicated with other malignancies (un cured within 5 years);
  • Confirmed positive EGFR or ALK driver genes by genetic testing;
  • Any condition requiring systemic therapy with corticosteroids (>10 mg prednisone per day or equivalent) or other immunosuppressive drugs before enrollment;
  • Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis;
  • Known history of HIV infection;
  • Untreated chronic hepatitis B patients, chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU/mL, or active hepatitis C virus (HCV) patients; (Note: Inactive hepatitis B surface antigen carriers, treated and stable hepatitis B patients (HBV DNA \< 500 IU/mL), and cured hepatitis C patients are eligible.);
  • Received live vaccine within 28 days before enrollment;
  • Simultaneously participating in another therapeutic clinical study;
  • Other conditions considered unsuitable for participation in this study by the investigator.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Multimodal Ablation Combined with Perioperative Tislelizumab and Chemotherapy

    Patients in this single arm will receive a multimodal ablation procedure, followed by perioperative tislelizumab in combination with platinum-based doublet chemotherapy , and subsequently undergo radical surgical resection. Adjuvant tislelizumab will be continued after surgery as per protocol.

    Device: Multimodal Ablation · Drug: Neoadjuvant therapy · Procedure: Surgery · Drug: Adjunctive therapy

Interventions

  • DeviceMultimodal Ablation

    CT-guided preoperative multimodal ablation performed with multimodal tumor therapy system.Target lung lesions are ablated within 2 weeks after subject enrollment.

  • DrugNeoadjuvant therapy

    Neoadjuvant tislelizumab (200 mg, IV, Q3W) combined with chemotherapy will be administered within 2 weeks after ablation. For patients with squamous NSCLC, cisplatin or carboplatin combined with paclitaxel will be used; for patients with non-squamous NSCLC, cisplatin or carboplatin combined with pemetrexed will be used, for a total of 3-4 cycles of treatment.

    Also known as: Tislelizumab

  • ProcedureSurgery

    Surgical resection will be performed within 4-6 weeks after the last neoadjuvant treatment. The pulmonary lesions (including the ablated lesions) will be radically resected via surgery.

  • DrugAdjunctive therapy

    Adjuvant therapy will be initiated within 2-8 weeks after surgery. Postoperative adjuvant therapy with tislelizumab (400 mg, Q6W) will be maintained for up to 1 year. Concomitant chemotherapy is allowed during this period based on guidelines/consensus or multidisciplinary team (MDT) discussion.

    Also known as: Tislelizumab

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What researchers measure

Primary outcomes

  1. Pathological Complete Response Rate

    Proportion of patients with no residual viable tumor cells in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant therapy.

    Time frame: Perioperative

Secondary outcomes

  1. Major Pathological Response Rate

    Proportion of patients with ≤10% residual viable tumor cells in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant therapy. Assessed by pathologist within 2 weeks after surgical resection.

    Time frame: Perioperative

  2. Event-Free Survival

    Time from start of treatment to the first occurrence of any of the following events: disease progression precluding surgical treatment, local or distant recurrence, or death from any cause. Patients without an event are censored at the date of last imaging assessment.

    Time frame: Through study completion, up to 5 years

  3. Overall Survival

    Time from enrollment to death due to any cause. Patients alive at last follow-up are censored at the last follow-up date. Lost-to-follow-up patients are censored at the last confirmed survival date.

    Time frame: Through study completion, up to 5 years

  4. Incidence and Severity of Adverse Events and Serious Adverse Events

    Safety will be assessed by monitoring the incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) graded according to NCI-CTCAE v6.0.

    Time frame: Through study completion

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07729670
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Responsible party
Sponsor
First posted
Jul 27, 2026
Start date
Jun 2026 (estimated)
Primary completion
Jun 2029 (estimated)
Completion
Jun 2031 (estimated)
Last update
Jul 27, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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