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

NCT ID: NCT06537505

Last Updated: 2024-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-05
• Study Completion Date: 2027-08-31

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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

microwave ablation combined with immunotherapy and anti-angiogenic drugs

microwave ablation combined with adebrelimab and apatinib

Group Type: EXPERIMENTAL

Adebrelimab

Intervention Type: DRUG

Q3W,IV

Apatinib

Intervention Type: DRUG

QoD

microwave ablation

Intervention Type: PROCEDURE

microwave ablation

microwave ablation combined with immunotherapy

microwave ablation combined with adebrelimab

Group Type: EXPERIMENTAL

Adebrelimab

Intervention Type: DRUG

Q3W,IV

microwave ablation

Intervention Type: PROCEDURE

microwave ablation

Interventions

Adebrelimab

Q3W,IV

Intervention Type: DRUG

Apatinib

QoD

Intervention Type: DRUG

microwave ablation

microwave ablation

Intervention Type: PROCEDURE

Other Intervention Names

SHR-1316

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beidahuang Industry Group General Hospital

OTHER

Sponsor Role: lead

Responsible Party

LiuMingyang

Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mingyang Liu

Role: CONTACT

redrumff@163.com

+86 451 5519 7857

Other Identifiers

SHR-1316-HLJ-010

Identifier Type: -

Identifier Source: org_study_id