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NCT Number: NCT06537505

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

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adebrelimab

Drug

Q3W,IV

Other names: SHR-1316

apatinib

Drug

QoD

Microwave ablation

Procedure

microwave ablation

Primary outcomes

  1. Objective Response Rate

    Time frame: up to 24 months

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

Secondary outcomes

  1. Disease control rate

    Time frame: up to 24 months

    Disease Control Rate determined usina RECIST V1.1 criteria.

  2. Progression-free Survival

    Time frame: up to 36 months

    Defined as the time from randomization to the first occurrence of disease progression

  3. Overall Survival

    Time frame: up to 36 months

    Defined as the time from randomization to death from any cause.

  4. incidence rate of AE

    Time frame: up to 36 months

    Incidence, nature, and severity of adverse events graded according to the NCI CCAE

Other outcomes

  1. explore immune resistance mechanisms

    Time frame: up to 36 months

    to explore immune resistance mechanisms

Study contacts

Contact information is provided by the study sponsor or research team.

Mingyang Liu

CONTACT

[email protected]

+86 451 5519 7857

Sponsors and collaborators

Lead sponsor

Beidahuang Industry Group General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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