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

NCT06537505 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-1316-HLJ-010
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Determined using RECIST V1.1 criteria, defined as best overall response (CR or PR)

  up to 24 months

Secondary Outcomes (4)

• Disease control rate

  up to 24 months

• Progression-free Survival

  up to 36 months

• Overall Survival

  up to 36 months

• incidence rate of AE

  up to 36 months

Other Outcomes (1)

• explore immune resistance mechanisms

  up to 36 months

Study Arms (2)

microwave ablation combined with immunotherapy and anti-angiogenic drugs

EXPERIMENTAL

microwave ablation combined with adebrelimab and apatinib

Drug: Adebrelimab; Drug: Apatinib; Procedure: microwave ablation

microwave ablation combined with immunotherapy

EXPERIMENTAL

microwave ablation combined with adebrelimab

Drug: Adebrelimab; Procedure: microwave ablation

Interventions

Adebrelimab DRUG

Q3W,IV

Also known as: SHR-1316

microwave ablation combined with immunotherapy; microwave ablation combined with immunotherapy and anti-angiogenic drugs

Apatinib DRUG

QoD

microwave ablation combined with immunotherapy and anti-angiogenic drugs

microwave ablation PROCEDURE

microwave ablation

microwave ablation combined with immunotherapy; microwave ablation combined with immunotherapy and anti-angiogenic drugs

Eligibility Criteria

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

You may qualify if:

• Patients with clinically confirmed advanced non-small cell lung cancer or hepatocellular carcinoma;
• Previously received systemic treatment;
• Expected survival period \> 3 months;
• Age: 18-75 years old, male or female;
• ECOG PS: 0-2 points;
• 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;
• 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;
• The patient voluntarily joined this study and signed the informed consent form.

You may not qualify if:

• 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.
• Patients with severe bleeding tendency and coagulation dysfunction that cannot be corrected in the short term;
• Patients with severe pulmonary fibrosis and pulmonary hypertension;
• Patients with infectious and radioactive inflammation around the lesion and skin infection at the puncture site that is not well controlled;
• Systemic infection, high fever \>38.5 ℃;
• Severe anemia, dehydration and severe nutritional metabolism disorder that cannot be corrected or improved in a short period of time;
• Poorly controlled malignant pleural effusion;
• Uncontrolled, symptomatic brain metastasis or a history of difficult-to-control mental illness or severe intellectual or cognitive impairment;
• 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;
• Congestive heart failure, uncontrollable arrhythmias, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack;
• Patients who cannot comply with the trial protocol or cannot cooperate with follow-up;
• History of psychotropic drug abuse, alcoholism or drug abuse;
• Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive;
• Those who are considered by the researchers to be unsuitable for participation in this trial.

Sponsors & Collaborators

• Beidahuang Industry Group General Hospital: lead

MeSH Terms

Interventions

apatinib

Central Study Contacts

Mingyang Liu

CONTACT

+86 451 5519 7857; redrumff@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 5, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share