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

An Exploratory Clinical Study of Microwave Ablation Combined With Immunotherapy ± Anti-angiogenic Drugs in the Treatment of Advanced Second-line and Above Solid Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Procedure: microwave ablation; Drug: Adebrelimab; Drug: Apatinib

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mingyang Liu; Phone Number: +86 451 5519 7857; Email: redrumff@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: microwave ablation combined with immunotherapy and anti-angiogenic drugs; microwave ablation combined with adebrelimab and apatinib	Procedure: microwave ablation; microwave ablation; Drug: Adebrelimab; Q3W,IV; Other Names: SHR-1316; Drug: Apatinib; QoD
Experimental: microwave ablation combined with immunotherapy; microwave ablation combined with adebrelimab	Procedure: microwave ablation; microwave ablation; Drug: Adebrelimab; Q3W,IV; Other Names: SHR-1316

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
explore immune resistance mechanisms	to explore immune resistance mechanisms	up to 36 months

Collaborators and Investigators

• Sponsor: Beidahuang Industry Group General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 5, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Estimated): August 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: SHR-1316-HLJ-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No