AzTrials
AzTrials

Carcinoma, Non-Small-Cell Lung (NSCLC)Phase 2NEOCTATCNCT07855965

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

A Phase 2 study testing Cryo-Thermal Ablation, Toripalimab and Platinum-based doublet chemotherapy in people with Carcinoma, Non-Small-Cell Lung (NSCLC), run by West China Hospital at 9 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Carcinoma, Non-Small-Cell Lung (NSCLC)
What is being tested?
Cryo-Thermal Ablation, Toripalimab and Platinum-based doublet chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
9 sitesChina
Study dates
10 Sep 2026to 5 Aug 2033
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis, Stage, and Resectability
  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
  • Clinical stage IB-IIIB according to the 9th edition IASLC/AJCC TNM classification.
  • For stage IB disease, only patients with a maximum tumor diameter of 4.0 cm (cT2aN0M0) are eligible.
  • The disease must be considered resectable by multidisciplinary team (MDT) assessment with curative-intent surgery planned after neoadjuvant treatment.
  • The primary lung lesion must be technically amenable to percutaneous biopsy and CT-guided Cryo-Thermal Ablation..
Show all 28Show fewer
  • No prior systemic or local anti-tumor therapy for the current NSCLC.
  • Age, Performance Status, and General Condition
  • Age 18-80 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Estimated life expectancy >6 months.
  • Able to understand and voluntarily sign the informed consent form and willing to comply with study treatment, specimen collection, and follow-up requirements.
  • Tumor Tissue and Pulmonary Function
  • Willing to provide tumor tissue and blood samples required by the study protocol.
  • Adequate pulmonary function for the planned treatment and subsequent pulmonary resection, including: FEV1 ≥1.2 L or ≥50% of predicted value; and predicted postoperative FEV1≥30% of predicted value.
  • Adequate Organ Function
  • Laboratory assessments performed within 7 days before the first study intervention must meet the following criteria:
  • Hemoglobin ≥9.0 g/dL;
  • absolute neutrophil count ≥1.0 × 10⁹/L;
  • platelet count ≥90 × 10⁹/L;
  • total bilirubin ≤2.0 × upper limit of normal (ULN);
  • alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤2.5 × ULN;
  • serum creatinine ≤2.0 mg/dL and creatinine clearance ≥60 mL/min;
  • adequate thyroid function. If thyroid-stimulating hormone (TSH) is outside the normal range, free T3 and free T4 must be within clinically acceptable limits; no clinically significant abnormality in cardiac enzyme testing;
  • international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5 × ULN, unless abnormalities are attributable to protocol-permitted anticoagulation.
  • Reproductive Requirements
  • Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (HCG) pregnancy test within 7 days before initiation of study treatment.
  • Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception from enrollment until at least 180 days after the last dose of study systemic therapy.

Who cannot join

  • Histological or Molecular Characteristics
  • Small-cell lung cancer (SCLC) or mixed histology containing a small-cell component.
  • Presence of protocol-defined actionable oncogenic alterations detected by tumor tissue and/or plasma-based molecular testing, including:
  • EGFR sensitizing or protocol-defined activating alterations, including exon 19 deletion, L858R, G719X, S768I, L861Q, or exon 20 insertion;
  • ALK rearrangement;
  • ROS1 rearrangement;
Show all 51Show fewer
  • MET exon 14 skipping alteration or protocol-defined MET amplification;
  • KRAS G12C;
  • BRAF V600E;
  • NTRK1/2/3 fusion;
  • RET rearrangement; or HER2 alteration as defined in the study protocol.
  • Contraindications to Percutaneous Biopsy or Cryo-Thermal Ablation
  • Active clinically significant hemoptysis, defined as ≥1/2 teaspoon of fresh blood, within 2 weeks before the planned procedure.
  • Clinically significant bleeding tendency or coagulation disorder that cannot be adequately corrected before biopsy or ablation.
  • Therapeutic anticoagulant or vitamin K antagonist treatment that cannot be safely interrupted or managed during the periprocedural period according to the study protocol and institutional practice. Stable anticoagulation may be permitted when appropriate periprocedural interruption or management is considered safe by the investigator.
  • Active infection involving the planned biopsy or ablation site or access pathway.
  • Any anatomical or clinical condition considered by the investigator to make percutaneous biopsy or combined Cryo-Thermal Ablation unsafe.
  • Clinically Significant Cardiovascular or Systemic Disease
  • Uncontrolled hypertension.
  • Unstable angina, myocardial infarction within 3 months before enrollment, New York Heart Association (NYHA) class II or higher heart failure considered clinically significant by the investigator, or severe/uncontrolled arrhythmia.
  • Severe or uncontrolled hepatic, renal, metabolic, or other systemic disease that could interfere with study treatment or assessment.
  • Immunotherapy-Related Contraindications
  • Active or suspected autoimmune disease requiring systemic treatment, except for conditions permitted by the protocol, such as vitiligo, type 1 diabetes mellitus, or adequately controlled autoimmune hypothyroidism.
  • History of autoimmune disease requiring systemic treatment with disease-modifying agents, corticosteroids, or immunosuppressive therapy within 2 years before enrollment, except as specifically permitted by the protocol.
  • Requirement for chronic systemic immunosuppressive treatment.
  • Systemic glucocorticoid treatment within 7 days before initiation of systemic study treatment, except physiologic replacement therapy equivalent to prednisone ≤10 mg/day.
  • Uncontrolled peripheral neuropathy of grade ≥2 or other condition that, in the investigator's judgment, would substantially increase the risk of study treatment.
  • Psychiatric, cognitive, or other conditions that would prevent adequate informed consent or compliance with study procedures.
  • Active or Clinically Significant Infection
  • Active tuberculosis or inadequately controlled tuberculosis treated within 1 year before enrollment.
  • Human immunodeficiency virus (HIV) infection with clinically significant immunodeficiency or acquired immunodeficiency syndrome (AIDS), as defined by the study protocol.
  • Active hepatitis B infection with HBV DNA above the protocol-defined acceptable limit.
  • Active hepatitis C infection with detectable HCV RNA.
  • Other uncontrolled active infection requiring systemic therapy that, in the investigator's judgment, would interfere with study treatment.
  • Pulmonary Conditions
  • Interstitial lung disease, interstitial pneumonia, pneumoconiosis, drug-induced pneumonitis, or other clinically significant diffuse pulmonary disease that may increase the risk of study treatment.
  • Severe impairment of pulmonary function incompatible with the planned ablation, systemic therapy, or subsequent surgical resection.
  • Clinically uncontrolled pleural or pericardial effusion. Participants whose effusion is adequately controlled and clinically stable after drainage may be eligible according to investigator assessment and the study protocol.
  • Other Malignancies
  • Another malignancy diagnosed within 2 years before enrollment, except malignancies with a negligible risk of metastasis or death that have been adequately treated, such as basal cell or squamous cell carcinoma of the skin or carcinoma in situ treated with curative intent.
  • Concurrent or Recent Treatments
  • Participation in another interventional clinical trial or receipt of another investigational drug or investigational device within 4 weeks before the first study intervention.
  • Receipt of anti-cancer traditional Chinese patent medicines or systemic immunomodulatory agents, including thymosin, interferons, or interleukins, within 2 weeks before initiation of study treatment.
  • Receipt of a live attenuated vaccine within 30 days before initiation of study treatment. Inactivated vaccines, including inactivated influenza vaccines, are permitted.
  • Pregnancy, Lactation, and Transplantation
  • Pregnancy or breastfeeding.
  • Unwillingness to comply with protocol-specified contraceptive requirements.
  • Previous organ or bone marrow transplantation, or planned transplantation during the study period.
  • Other Exclusion Criteria
  • Known severe hypersensitivity or contraindication to toripalimab, protocol-specified chemotherapy agents, their excipients, or materials used in the ablation procedure.
  • Any other medical, psychological, social, or logistical condition that, in the investigator's judgment, makes the participant unsuitable for study enrollment or could interfere with treatment safety, protocol compliance, or interpretation of study results.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Beinuo Wang, MD contact

+86-191-0807-4950

wang_beinuo@163.com

9 sites in 1 country

China9 sites, 9 recruiting

  • The Third People's Hospital of Chengdu

    Chengdu, Sichuan, 610031

    Yi Yang, +86 28 61312288, 191888@qq.com

    Not yet recruiting

  • Sichuan Cancer Hospital & Institute

    Chengdu, Sichuan, 610041

    Xuefeng Leng, +86 28 85420305, leng724@163.com

    Not yet recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Hu Liao, MD, 19108074950, drliaohu@scu.edu.cn

    Recruiting

  • Public Health Clinical Center of Chengdu

    Chengdu, Sichuan, 610066

    Xiaojun Yao, +86 28 65233185, flyingyao@163.com

    Not yet recruiting

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

    Jiangtao Pu, 18980605130, pjtapollo@sohu.com

    Not yet recruiting

  • Meishan People's Hospital

    Meishan, Sichuan, 620010

    Qiwei Kan, +86 28 38509261, 646967480@qq.com

    Not yet recruiting

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637000

    Maoyong Fu, +86 817 2262120, fumaoyongmd@163.com

    Not yet recruiting

  • Suining Central Hospital

    Suining, Sichuan, 629000

    Haining Zhou, +86 825 2291234, haining_zhou@zmu.edu.cn

    Not yet recruiting

  • Zigong Fourth People's Hospital

    Zigong, Sichuan, 643000

    Yun Huang, +86 813 2102560, zgsdsrmyygcp@163.com

    Not yet recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Cryo-Thermal Ablation Combined With Toripalimab and Chemotherapy as Neoadjuvant Treatment for Resectable Stage IB-IIIB Non-Small Cell Lung Cancer: A Multicenter, Single-Arm, Prospective Phase II Clinical 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.

Read more

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.

Being tested
Cryo-Thermal Ablation, Toripalimab, Platinum-based doublet chemotherapy
Keywords
Neoadjuvant therapy, Resectable non-small cell lung cancer, Ablation, Toripalimab, PD-1 inhibitor, Chemoimmunotherapy
Medical subject headings
Carcinoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cryo-Thermal AblationProcedure or surgery

    Also called Ablation

    Cryo-Thermal Ablation is a CT-guided percutaneous local ablation procedure performed on the primary lung tumor before initiation of neoadjuvant systemic therapy. Under CT guidance, one or more ablation probes are placed percutaneously into the target lesion. Sequential cryogenic and thermal treatment is delivered according to the study protocol and device operating instructions. Technical parameters, including probe placement, treatment cycles, treatment duration, and target temperatures, will be standardized according to the protocol.

  • ToripalimabDrug

    Toripalimab, an anti-programmed cell death protein 1 (PD-1) monoclonal antibody, will be administered intravenously at a dose of 240 mg every 3 weeks (q3w) in combination with platinum-based doublet chemotherapy for 3 planned cycles following Cryo-Thermal Ablation. Dose interruption, delay, or discontinuation will be permitted when clinically indicated for treatment-related toxicity.

  • Platinum-based doublet chemotherapyDrug

    Participants will receive protocol-specified platinum-based doublet chemotherapy in combination with toripalimab every 3 weeks for 3 planned cycles following Cryo-Thermal Ablation. The specific regimen will be selected according to tumor histology and the study protocol. Chemotherapy dosing, administration, dose modification, and supportive treatment will follow the protocol-defined regimen and standard clinical practice. After neoadjuvant therapy, disease reassessment will be performed before curative-intent surgical resection.

Study groups in NCT07855965
Study groupRoleWhat they receive
Neoadjuvant Cryo-Thermal Ablation Combined With Toripalimab and Platinum-Based Doublet ChemotherapyExperimentalParticipants will receive CT-guided Cryo-Thermal Ablation followed by 3 planned cycles of toripalimab plus histology-appropriate platinum-based doublet chemotherapy administered every 3 weeks, followed by curative-intent surgical resection after preoperative reassessment.
Receives: Procedure: Cryo-Thermal Ablation; Drug: Toripalimab; Drug: Platinum-based doublet chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Complete Response (pCR) Rate

    The proportion of enrolled participants who achieve pathological complete response (pCR), defined as no residual viable tumor cells in the resected primary tumor and all sampled regional lymph nodes after neoadjuvant treatment (ypT0N0).

    Participants who do not undergo surgical resection or for whom pathological response cannot be adequately assessed will not be considered to have achieved pCR in the primary efficacy analysis.

    Measured: At pathological evaluation of the surgical resection specimen, with surgery planned approximately 4-6 weeks after the final neoadjuvant treatment.

Secondary outcomes (7)

  1. Objective Response Rate (ORR)

    The proportion of enrolled participants who achieve a complete response (CR) or partial response (PR) as their radiographic tumor response before surgery, as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: At preoperative radiographic reassessment, approximately 4-6 weeks after the final neoadjuvant treatment.

  2. Major Pathological Response (MPR) Rate

    The proportion of enrolled participants who achieve major pathological response (MPR), defined as ≤10% residual viable tumor cells within the primary tumor bed in the resected lung specimen after neoadjuvant treatment, based on pathological assessment according to IASLC recommendations.

    Pathological response in regional lymph nodes will be assessed and reported separately and will not be included in the primary definition of MPR.

    Measured: At pathological evaluation of the surgical resection specimen, with surgery planned approximately 4-6 weeks after the final neoadjuvant treatment.

  3. R0 resection rate

    The proportion of participants undergoing surgical resection who achieve an R0 resection, defined as complete macroscopic resection of the tumor with microscopically negative surgical margins and no residual tumor at the resection margins.

    Measured: At surgical and pathological evaluation of the resection specimen, with surgery planned approximately 4-6 weeks after the final neoadjuvant treatment.

  4. Event-Free Survival (EFS)

    Event-free survival (EFS) is defined as the time from enrollment to the first occurrence of any of the following events: radiographic disease progression; local disease progression resulting in unresectability; inability to undergo the planned curative-intent surgery because of treatment-related toxicity or deterioration in clinical condition attributable to study treatment; failure to achieve tumor resection because of intraoperative unresectability; local or distant disease recurrence after surgery; or death from any cause. Participants without an EFS event will be censored at the date of the last disease assessment.

    Measured: From enrollment until the first EFS event, death, last disease assessment, or end of follow-up, up to approximately 5 years.

  5. Overall Survival (OS)

    Overall survival (OS) is defined as the time from enrollment to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive.

    Measured: From enrollment until death from any cause or the end of follow-up, up to approximately 5 years.

  6. Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score

    Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The Global Health Status/Quality of Life scale is transformed to a score ranging from 0 to 100, with higher scores indicating better overall health status and quality of life. Changes from baseline will be evaluated across predefined perioperative assessment time points.

    Measured: Baseline before Cryo-Thermal Ablation; preoperative assessment approximately 4-6 weeks after the final neoadjuvant treatment; and approximately 30 days after surgical resection.

  7. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

    The proportion of participants who experience one or more treatment-emergent adverse events (TEAEs). Adverse events will be assessed for type, severity, and relationship to study treatment and graded according to NCI-CTCAE version 5.0. Safety assessments will include events associated with Cryo-Thermal Ablation, neoadjuvant chemoimmunotherapy, and the perioperative treatment course.

    Measured: From Cryo-Thermal Ablation through 30 days after surgical resection; for participants not undergoing surgery, through 30 days after discontinuation of protocol-defined treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2026
  2. Study start10 Sep 2026
  3. Primary completion5 Aug 2028 (estimated)
  4. Study completion5 Aug 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07855965
Sponsor's protocol ID
NEOCTATC-2026-09
Acronym
NEOCTATC
Status last verified
Sep 2026
First submitted
9 Sep 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data are not planned for public sharing because the study includes sensitive clinical, genomic, and multi-omics data. Data sharing may be considered in accordance with participant consent, ethics committee approval, institutional policies, and applicable data protection requirements.

Publications

  • Mooradian MJ, Fintelmann FJ, LaSalle TJ, Simon J, Graur A, Muzikansky A, Mino-Kenudson M, Shalhout S, Kaufman HL, Jenkins RW, Lawrence D, Lawless A, Sharova T, Uppot RN, Fang J, Blaum EM, Gonye ALK, Gushterova I, Boland GM, Azzoli C, Hacohen N, Sade-Feldman M, Sullivan RJ. Cryoablation and post-progression immune checkpoint inhibition in metastatic melanoma: a phase II trial. Nat Commun. 2024 Aug 27;15(1):7357. doi: 10.1038/s41467-024-51722-x.

    PubMed 39191779

  • Gu S, Luo Q, Zhang Y, Qian L, Chen K, Liang F, Hu Y, Zhou R, Wang Y, Liu J, Ning Z, Xu L, Meng Z, Li Y, Wang P. Cryoablation plus sintilimab and lenvatinib in advanced or metastatic intrahepatic cholangiocarcinoma: a phase 2 trial. Nat Cancer. 2026 Jan;7(1):60-79. doi: 10.1038/s43018-025-01058-2. Epub 2025 Nov 1.

    PubMed 41176543

  • Lu S, Zhang W, Wu L, Wang W, Zhang P; Neotorch Investigators; Fang W, Xing W, Chen Q, Yang L, Mei J, Tan L, Sun X, Xu S, Hu X, Yu G, Yu D, Yang N, Chen Y, Shan J, Xing L, Tian H, Zhang X, Zhou M, Fang H, Wu G, Liu Y, Ye M, Cao L, Jiang J, Li X, Zhu L, Li S, Kang M, Zhong A, Chen K, Wu N, Sun Q, Ma H, Cai K, Wang C, Lin G, Zhu K, Zhang Y, Zhang X, Hu H, Zhang W, Chen J, Yang Z, Hang X, Hu J, Huang Y, Zhang Z, Zhang L, Zhang L, Liu L, Lin D, Zhang J, Chen G, Li Y, Zhu L, Wang W, Yu W, Cao D, Keegan P, Yao S. Perioperative Toripalimab Plus Chemotherapy for Patients With Resectable Non-Small Cell Lung Cancer: The Neotorch Randomized Clinical Trial. JAMA. 2024 Jan 16;331(3):201-211. doi: 10.1001/jama.2023.24735.

    PubMed 38227033

  • Liu Z, Yang Z, Wu J, Zhang W, Sun Y, Zhang C, Bai G, Yang L, Fan H, Chen Y, Zhang L, Jiang B, Liu X, Ma X, Tang W, Liu C, Qu Y, Yan L, Zhao D, Wu Y, He S, Xu L, Peng L, Chen X, Zhou B, Zhao L, Zhao Z, Tan F, Zhang W, Yi D, Li X, Gao Q, Zhang G, Wang Y, Yang M, Fu H, Guo Y, Hu X, Cai Q, Qi L, Bo Y, Peng H, Tian Z, She Y, Zou C, Zhu L, Cheng S, Zhang Y, Zhong W, Chen C, Gao S, Zhang Z. A single-cell atlas reveals immune heterogeneity in anti-PD-1-treated non-small cell lung cancer. Cell. 2025 May 29;188(11):3081-3096.e19. doi: 10.1016/j.cell.2025.03.018. Epub 2025 Mar 26.

    PubMed 40147443

  • Leiter A, Veluswamy RR, Wisnivesky JP. The global burden of lung cancer: current status and future trends. Nat Rev Clin Oncol. 2023 Sep;20(9):624-639. doi: 10.1038/s41571-023-00798-3. Epub 2023 Jul 21.

    PubMed 37479810

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cryo-Thermal Ablation, Toripalimab and Platinum-based doublet chemotherapy in people with Carcinoma, Non-Small-Cell Lung (NSCLC), run by West China Hospital at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Beinuo Wang, MD (+86-191-0807-4950, wang_beinuo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (pCR) Rate (time frame: At pathological evaluation of the surgical resection specimen, with surgery planned approximately 4-6 weeks after the final neoadjuvant treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07855965, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in