Efficacy and Safety of Microwave Ablation Combined With Camrelizumab and Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer: a Multicenter, Open, Prospective Study

NCT05532527 | Unknown

• 1 other identifier: NSCLC-MWA-001
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy and safety of microwave ablation combined with Camrelizumab and chemotherapy in the treatment of patients with advanced non-small cell lung cancer.

Conditions

Nsclc

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression free survival

  Up to 24 months

Secondary Outcomes (3)

• OS

  Up to 24 months

• ORR

  Up to 24 months

• safety

  Up to 24 months

Other Outcomes (1)

• Immune function

  Up to 24 months

Study Arms (1)

Study group

EXPERIMENTAL

Microwave ablation combined with Camrelizumab and chemotherapy

Drug: Microwave ablation combined with Camrelizumab and chemotherapy

Interventions

Microwave ablation combined with Camrelizumab and chemotherapy DRUG

Microwave ablation combined with Camrelizumab and chemotherapy

Also known as: Camrelizumab

Study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have fully understood and voluntarily signed the informed consent for this study 2.18-75 years old 3.Stage IIIB-IV non-small cell lung cancer patients with histologically or cytologically confirmed EGFR/ALK- 4.No previous systemic antitumor therapy for the target lesion 5.ECOG score is 0-2 6.The predicted survival time was ≥3 months 7.At least one measurable lesion (according to RECIST 1.1) other than the lesion that underwent microwave ablation 8.The function of major organs is normal, and the test results during screening must meet the following requirements:
• Blood routine (no blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage colony-stimulating factor (GM-CSF) treatment within 14 days before screening) :
• A. Hemoglobin (Hb) ≥ 90 g/L; B. Neutrophil count (ANC) ≥ 1.5×109/L; C. Platelet count (PLT) ≥ 80 ×109/L;
• Biochemical tests shall meet the following standards:
• A. Total bilirubin (TBIL) \< 1.5 ULN; B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 ULN and \< 5 ULN in patients with liver metastases; C. Serum creatinine (Cr) ≤ 1.5 ULN or endogenous creatinine clearance \> 50ml/min (cockcroft-gault formula); D. Urine routine test results showed urinary protein (UPRO) \< 2+ or 24-hour urinary protein quantification \<1g;
• Echocardiography: left ventricular ejection fraction (LVEF) ≥50%;
• Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤1.5×ULN; 9. Contraception: Women of reproductive age should agree that they must use effective contraception during and for 6 months after the study; Had a negative serum or urine pregnancy test within 7 days before study enrollment and had to be non-lactating; Men should agree to use contraception during the study and for 6 months after the end of the study

You may not qualify if:

• Allergic to treatment drugs;
• EGFR/ALK mutation positive;
• There are high risk factors for local treatment complications such as bleeding, fistula and perforation;
• Patients with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis and severe pulmonary function impairment (maximum volume \< 40%);
• Patients with coagulopathy who have severe bleeding tendency and cannot be corrected in a short time (prothrombin time \>18 s, prothrombin activity \<40%);
• Anticoagulant therapy and/or antiplatelet drugs (except dabigatran, rivaroxaban and other new oral anticoagulants) were stopped for no more than 5 to 7 days before ablation.
• Extensive pleural metastases with massive pleural effusion;
• Patients with active brain metastases: untreated, newly diagnosed and/or growing lesions or symptomatic brain metastases (patients with stable symptoms after treatment of brain metastases were eligible to remain stable for at least 4 weeks);
• Infection and radiation inflammation around the lesion, skin infection at the puncture site without good control, systemic infection, high fever \>38.5 ℃;
• Patients were using immunosuppressive agents or systemic hormone therapy (dose \>10mg/ day prednisone or other efficacy hormone) to achieve immunosuppression and continued to use them within 2 weeks before enrollment;
• Has had or is currently suffering from other malignant tumours within 5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer or other tumours/cancers that have undergone radical treatment and have shown no signs of disease for at least 5 years; 65/5000
• Had received antitumor drug therapy (e.g., chemotherapy, hormone therapy, immunotherapy, antibody therapy, radiotherapy, etc.) 4 weeks before or within 4 weeks of the first dose, with the exception of palliative radiotherapy to bone for pain relief;
• Had undergone major surgery within 4 weeks before the first dose or was expected to undergo major surgery during the study;
• Patients whose imaging showed that the tumor had invaded important blood vessels or who were judged by the investigator to be highly likely to invade important blood vessels during the subsequent study and cause fatal massive bleeding;
• Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months before enrollment; New York Heart Association (NYHA) grade of congestive heart failure ≥2; Arrhythmia (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women); Left ventricular ejection fraction (LVEF) \<50%;

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

camrelizumab; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 8, 2022
• Study Start: September 20, 2022
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2025
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share