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Not yet recruiting NCT06537505

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

Phase II Interventional Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adebrelimab, Apatinib, microwave ablation.
Who it may be relevant to
Registry conditions: Solid Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Adebrelimab
    Q3W,IV
  • Drug Apatinib
    QoD
  • Procedure microwave ablation
    microwave ablation

Primary outcome measures

  • Objective Response Rate [Time frame: up to 24 months]
Secondary outcome measures (4)
  • Disease control rate [Time frame: up to 24 months]
  • Progression-free Survival [Time frame: up to 36 months]
  • Overall Survival [Time frame: up to 36 months]
  • incidence rate of AE [Time frame: up to 36 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06537505 · SHR-1316-HLJ-010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗