A Study of Microwave Ablation Combined With Immunotherapy ± Anti-angiogenic Drugs in the Treatment of Solid Tumors

Phase 2

Not yet recruiting

• Conditions: Solid Tumor
• Interventions: Drug: Adebrelimab; Drug: Apatinib; Procedure: microwave ablation

• Registration Number: NCT06537505
• Lead Sponsor: Beidahuang Industry Group General Hospital

Brief Summary

This is a multi-center, phase Il trial to evaluate the efficacy and safety of microwave ablation combined with immunotherapy ± anti-angiogenic drugs in the treatment of advanced second-line and above solid tumors.

Detailed Description

This study plans to recruit 60 patients witha dvanced second-line and above solid tumors observe and evaluate the effectiveness and safety of microwave ablation combined with immunotherapy ± anti-angiogenic drugs.

Study Timeline

• Study First Submitted: 2024-07-29
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Study Start: 2024-08-05
• Study First Posted: 2024-08-05
• Last Update Posted: 2024-08-05
• Primary Completion: 2027-04-01
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients with clinically confirmed advanced non-small cell lung cancer or hepatocellular carcinoma;
2. Previously received systemic treatment;
3. Expected survival period > 3 months;
4. Age: 18-75 years old, male or female;
5. ECOG PS: 0-2 points;
6. The function of important organs meets the following requirements: a) Absolute neutrophil count ≥1.5×109/L, platelet ≥90×109/L, hemoglobin ≥90g/dL; b) Bilirubin ≤3 times ULN (patients drained by retrograde technique can be included); ALT and AST ≤5 times ULN, albumin>35g/ml, prothrombin time prolonged <6 seconds; c) Creatinine <120 μmol/L, or MDRD creatinine clearance >60 mL/min;
7. Women of childbearing age must have a negative pregnancy test (βHCG) before starting treatment, and women of childbearing age and men (having sexual relations with women of childbearing age) must agree to use effective contraceptive measures uninterruptedly during treatment and for 6 months after the last treatment dose;
8. The patient voluntarily joined this study and signed the informed consent form.

Exclusion Criteria

1. Patients who have had other malignant tumors in the past or at the same time within 5 years, but excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, superficial or non-invasive bladder cancer, etc.
2. Patients with severe bleeding tendency and coagulation dysfunction that cannot be corrected in the short term;
3. Patients with severe pulmonary fibrosis and pulmonary hypertension;
4. Patients with infectious and radioactive inflammation around the lesion and skin infection at the puncture site that is not well controlled;
5. Systemic infection, high fever >38.5 ℃;
6. Severe anemia, dehydration and severe nutritional metabolism disorder that cannot be corrected or improved in a short period of time;
7. Poorly controlled malignant pleural effusion;
8. Uncontrolled, symptomatic brain metastasis or a history of difficult-to-control mental illness or severe intellectual or cognitive impairment;
9. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only requires hormone replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;
10. Congestive heart failure, uncontrollable arrhythmias, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack;
11. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up;
12. History of psychotropic drug abuse, alcoholism or drug abuse;
13. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive;
14. Those who are considered by the researchers to be unsuitable for participation in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
microwave ablation combined with immunotherapy and anti-angiogenic drugs	microwave ablation	microwave ablation combined with adebrelimab and apatinib
microwave ablation combined with immunotherapy	microwave ablation	microwave ablation combined with adebrelimab
microwave ablation combined with immunotherapy and anti-angiogenic drugs	Adebrelimab	microwave ablation combined with adebrelimab and apatinib
microwave ablation combined with immunotherapy and anti-angiogenic drugs	Apatinib	microwave ablation combined with adebrelimab and apatinib
microwave ablation combined with immunotherapy	Adebrelimab	microwave ablation combined with adebrelimab

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	up to 24 months	Determined using RECIST V1.1 criteria, defined as best overall response (CR or PR)

Secondary Outcome Measures

Name	Time	Method
incidence rate of AE	up to 36 months	Incidence, nature, and severity of adverse events graded according to the NCI CCAE
Overall Survival	up to 36 months	Defined as the time from randomization to death from any cause.
Disease control rate	up to 24 months	Disease Control Rate determined usina RECIST V1.1 criteria.
Progression-free Survival	up to 36 months	Defined as the time from randomization to the first occurrence of disease progression