Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC

Sponsor
The Central Hospital of Lishui City
Study ID
NCT06364046
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Drug-eluting beads bronchial arterial chemoembolization — PROCEDURE
    Drug-eluting beads bronchial arterial chemoembolization generally uses platinum-containing two-drug chemotherapy "platinum (cisplatin, carboplatin, nedaplatin) combined treatment, and drug-loaded microspheres are loaded with irinotecan. The dose of chemotherapy drugs is set to 75mg/m2 of platinum, and the dose of chemotherapy through catheter infusion is reduced by 25%. The dose of drug-loaded drugs is irinotecan 80mg/ m2. Chemotherapy was perfused first, followed by embolization with drug-loaded microspheres, until the blood flow in the artery supplying the tumor slowed down and approached stagnation. The number of DEB-BACE treatments is determined by the investigator, and is given as needed according to the patient's condition, usually 1-2 times, with an interval of 28±10 days.
  • Serplulimab — DRUG
    Programmed cell death protein 1 inhibitor fixation was treated with serplulimab (Fuhong Hanlin Co., LTD.). It is administered by intravenous infusion, and the recommended dose is 200 mg, given once every 21 days. The medication will last for two years until disease progression or intolerable toxicity occurs. During immunotherapy, immunosuppressive agents will not be replaced and the dose will not be adjusted.
  • Intravenous chemotherapy — PROCEDURE
    Intravenous chemotherapy with irinotecan 65mg/m2 on day 1 and day 8, given once every 21 days

Study Details

This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice.

Key Dates

Start date
Apr 1, 2024
Status verified
Apr 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab
  • Active Comparator: Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab

Primary Outcome Measure

Objective response rate [ Time Frame: Proportion of patients who achieved complete remission (CR) or partial remission (PR) according to mRECIST criteria at 1 month, 3 months, and 6 months , assessed up to 12 months ]

Central Contacts

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