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Stage IV Lung Squamous Cell Carcinoma Treated With or Without Bronchial Artery Chemoembolization After First-line Chemotherapy and Immunotherapy

ConditionLung Squamous Cell Carcinoma Stage IV
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

This study intends to carry out prospective, randomized controlled clinical trials in many centers across the country to compare the efficacy and safety of immunotherapy after standard first-line chemotherapy or immunotherapy combined with interventional bronchial artery chemoembolization for stage IV lung squamous cell carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Squamous cell carcinoma of the lung confirmed by histology or cytology;

According to the TNM staging system of the 9th edition of American Cancer Association, it was assessed as stage IV.

Has received standard first-line chemotherapy immunotherapy for 4~6 cycles, and achieved partial remission or disease stability according to the efficacy evaluation of RECIST1.1;

The patient is 18-80 years old;

Disqualifiers

There is epidermal growth factor receptor (EGFR) sensitive mutation or anaplasticlymphomakinase (ALK) gene translocation;

Have a history of allergy to contrast agents or chemotherapy drugs;

Received other anti-tumor treatments other than standard first-line chemotherapy immunotherapy;

Arrhythmia with myocardial ischemia or myocardial infarction above grade II and poor control (including QTc interval ≥450ms for men and ≥ 470 ms for women);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immunotherapy combined with interventional therapy group

    Procedure/Surgery

    Tislelizumab 200mg, intravenous infusion, every 3 weeks, for 2 years. Simultaneously, the patient undergoes 1-3 sessions of transbronchial chemoembolization (BACE). A follow-up enhanced CT scan of the lungs and mediastinum is performed 4-6 weeks after BACE. Based on the results, the investigator will assess whether further BACE is necessary, with a maximum of 3 BACE sessions per patient.

  • Immunotherapy group

    Drug

    Tislelizumab 200 mg, IV infusion, Q3W, maintenance for 2 years. Follow up with enhanced CT scans of the lungs and mediastinum every 4-6 weeks, and assess efficacy according to RECIST 1.1 criteria.

Treatment groups

166 Participants
are divided into 2 treatment groups
Group A: Immunotherapy groupActive comparator 1 intervention
Group B: Immunotherapy combined with interventional therapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival

From date of randomization until the date of first documented progression or date of death from any cause

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

Secondary outcomes

1

Overall Survival

From date of randomization until the date of death from any cause

Time frame
From date of randomization until the date of death from any cause, 6,12, 24 months or more, through study completion.
2

Objective response rate

Proportion of patients with reduction in stable in tumor burden of a predefined amount

Time frame
2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months
3

Disease control rate

Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount

Time frame
2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: