Clinical trial NCT06537505: A Study of Microwave Ablation Combined With Immunotherapy ± Anti-angiogenic Drugs in the Treatment of Solid Tumors
Official title: An Exploratory Clinical Study of Microwave Ablation Combined With Immunotherapy ± Anti-angiogenic Drugs in the Treatment of Advanced Second-line and Above Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Solid Tumor
Lead sponsor: Beidahuang Industry Group General Hospital
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate
timeFrame: up to 24 months
Secondary outcomes:
measure: Disease control rate
timeFrame: up to 24 months
measure: Progression-free Survival
timeFrame: up to 36 months
measure: Overall Survival
timeFrame: up to 36 months
measure: incidence rate of AE
timeFrame: up to 36 months
Other outcomes:
measure: explore immune resistance mechanisms
timeFrame: up to 36 months
Locations:
Study officials:
References: