Clinical trial · Interventional
Microwave Ablation in Combination With Camrelizumab Versus Camrelizumab in Metastatic Non-small-cell Lung Cancer
Shandong Provincial Hospital Affiliated to Shandong University
NCT04102982CI-TRIAL-00048047MWA in NSCLCunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Camrelizumab plus microwave ablation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Microwave ablation plus camrelizumab group
- description
- Patients in the group are treated with Microwave ablation in the primary tumor, followed by camrelizumab.
- interventionNames
- Other: Camrelizumab plus microwave ablation
- type
- PLACEBO_COMPARATOR
- label
- Camrelizumab group
- description
- Patients in the group are treated with camrelizumab alone.
- interventionNames
- Drug: Camrelizumab
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- The proportion of Patients achieved complete response or partial response up to 16 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18 to 75 years old 2. Cytologically or pathologically verified non-small cell lung cancer (NSCLC) 3. Patients with distant metastases or postoperative recurrence 4. EGFR or ALK sensitive mutations are negative (all patients, including non-adenocarcinoma patients) 5. At least one line of platinum-based doublet chemotherapy was administrated 6. Eastern Cancer Cooperative Group（ECOG）Performance Status（PS）of 0 to 1 7. At least two measurable tumors (in other words a measurable tumor lesion exclusive primary tumors) 8. Asymptomatic brain metastases or symptomatic brain metastases under control 9. If treated with irradiation，at least one month interval between radiation and randomization 10）Cardiopulmonary function, laboratory test indicators without ablation or chemotherapy contraindications 11\) Informed conssent can be obtained 12) Sufficient tissue specimens for PD-L1 or TMB or blood samples were provided (1 week before treatment, 1 week after ablation, and once every two months for immune evaluation) for subsequent analysis Exclusion Criteria: 1. Mixed lung cancer contains neuroendocrine tumor, small cell lung cancer or sarcoma 2. Suffering from other malignant tumors within five years 3. EGFR, ALK sensitive mutations are positive or unknown 4. ECOG PS≥2 5. Uncontrolled pleural effusion or pericardial effusion 6. Uncontrolled symptomatic brain metastases 7. Previously anti-PD-1, anti-PD-L1, anti-CTLA-4 or Car-T immunotherapy 8. severe interstitial pneumonia with severe diffuse dysfunction 9. Autoimmune diseases require long-term hormone therapy patients 10. Patients required consistent application of prednisone 11. Uncontrolled pulmonary infection or antibiotics stopped within 1 month 12. Acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month 13. Patients during pregnancy or lactation 14. Life expectance of 3 months or less
References
Publications (0)
Data not yet available
No reference posted for this study.