New hope for advanced lung cancer: heat therapy plus drugs tested after first treatment fails
NCT ID NCT07528274
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new approach for people with advanced non-small cell lung cancer whose disease has worsened after initial immunotherapy and chemotherapy. Participants will receive a combination of microwave ablation (using heat to destroy tumors), the immunotherapy drug tislelizumab, and the chemotherapy drug docetaxel. The goal is to see if this combination can delay cancer progression. About 20 adults will take part in this phase 2 trial.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with cytologically or histologically confirmed non-small cell lung cancer (NSCLC), classified as stage IIIB, IIIC, or IV (AJCC 9th edition) and not eligible for curative treatment. * Male or female patients aged ≥18 years who have provided written informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of more than 6 months, and deemed suitable for microwave ablation by the investigator. * Patients must have previously received first-line treatment with tislelizumab in combination with chemotherapy and have documented disease progression based on imaging assessments prior to enrollment. Disease progression must occur ≥6 months after initiation of first-line tislelizumab plus chemotherapy, with or without concomitant anti-angiogenic therapy. * Adequate organ and bone marrow function, defined as follows: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L Platelet count ≥100 × 10⁹/L Hemoglobin ≥90 g/L White blood cell count ≥3.0 × 10⁹/L Hepatic function: Total bilirubin \<1.5 × the upper limit of normal (ULN) Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), and alkaline phosphatase (ALP) ≤2.5 × ULN In patients with liver metastases: AST and ALT ≤5.0 × ULN In patients with liver and/or bone metastases: ALP ≤5.0 × ULN Renal function: Serum creatinine ≤1.5 × ULN Urine protein \<2+ on urinalysis; if baseline urine protein is ≥2+, a 24-hour urine protein ≤1.0 g is required Coagulation function: International normalized ratio (INR) ≤1.5 Activated partial thromboplastin time (aPTT) ≤1.5 × ULN * Cardiac function defined as left ventricular ejection fraction (LVEF) ≥50%. * Ability to communicate effectively with the investigator and to comply with study-related visits, treatment, laboratory tests, and other study requirements. Exclusion Criteria: Participants meeting any of the following criteria will be excluded from the study: * Diagnosis of small cell lung cancer (SCLC), including mixed small cell and non-small cell lung cancer. * Presence of symptomatic brain metastases at the start of treatment. * Concurrent participation in another interventional clinical trial for cancer treatment. * History of tracheoesophageal fistula, gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 6 months prior to treatment initiation. * Presence of severe cardiovascular or cerebrovascular disease, including but not limited to: Cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, or significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization; Unstable angina; Heart failure classified as New York Heart Association (NYHA) class ≥ II; Mean resting corrected QT interval (QTc) \>470 ms; Any clinically significant resting electrocardiogram (ECG) rhythm, conduction, or morphological abnormalities, such as complete left bundle branch block, third-degree atrioventricular (AV) block, second-degree AV block, or PR interval \>250 ms; Any factors that increase the risk of QTc prolongation or arrhythmic events, including heart failure, electrolyte abnormalities (serum/plasma potassium \< LLN; magnesium \< LLN; calcium \< LLN), congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death of a first-degree relative before the age of 40, or concomitant use of medications known to prolong the QT interval and induce torsades de pointes. * Major surgical procedures performed within 4 weeks prior to enrollment or planned during the study period. * Bleeding tendency, high risk of bleeding, or coagulation disorders, including thrombotic events within 6 months prior to randomization and/or history of hemoptysis within 3 months prior to randomization (defined as ≥2.5 mL per episode). * Presence of unhealed wounds, active gastrointestinal ulcers, or fractures (excluding healed historical fractures). * Known or suspected hypersensitivity to tislelizumab and/or any of its excipients. * Pregnant or breastfeeding women. * Women of childbearing potential or male participants who are unwilling to use effective contraception during the study and for 6 months after the last dose of study treatment. * Any other condition that, in the opinion of the investigator, would render the participant unsuitable for enrollment in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Cancer Hospital Airport Hospital
RECRUITINGTianjin, Tianjin Municipality, 300308, China
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