Serplulimab Combined With Cryoablation for Early-Stage Non-Small Cell Lung Cancer
ConditionEarly Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorXi Junjie
About this trial
The goal of this clinical trial is to learn if serplulimab combined with cryoablation can effectively treat early-stage non-small cell lung cancer (NSCLC) in adults who are not eligible for or decline surgery or radiotherapy. The main questions it aims to answer are:
What is the objective response rate (ORR) after combination treatment with serplulimab and cryoablation? What are the progression-free survival (PFS), overall survival (OS), 1-year OS rate, and safety outcomes? This is a single-arm, phase II study with no comparison group.
Participants will:
Receive cryoablation under CT guidance to locally ablate the tumor Receive intravenous serplulimab (300 mg every 3 weeks) for up to 6 cycles Undergo regular imaging and laboratory tests to assess response and monitor safety Provide blood and tissue samples for optional biomarker research The study will enroll 25 patients with stage Ia NSCLC (tumor size \>1 cm and ≤3 cm, no ground-glass opacity, EGFR/ALK/ROS1 wild-type) and aims to explore the potential of combining local and systemic immunotherapy in non-surgical candidates.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Known history of severe hypersensitivity to any monoclonal antibody (Grade >3, per NCI-CTCAE v5.0).
Trial design
Design model
Single group
Treatments tested in this trial
Serplulimab
DrugPD-1 inhibitor, 300 mg intravenous infusion, once every 3 weeks (Q3W) for up to 6 cycles, starting after cryoablation recovery and in the absence of major procedural complications.
CT-guided Cryoablation
Procedure/SurgeryPercutaneous cryoablation performed under CT guidance to achieve local tumor ablation. Procedure done once (per-protocol) prior to systemic therapy.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Serplulimab + CryoablationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
ORR is defined as the proportion of patients who achieve either a complete response (CR) or partial response (PR) as assessed by investigators using modified Response Evaluation Criteria in Solid Tumors (mRECIST, 2019). Radiological evaluations will be conducted at regular intervals to determine tumor response. The evaluation will be based on measurable target lesions at baseline and follow-up imaging.
Time frame
Up to 12 monthsSecondary outcomes
1
Progression-Free Survival (PFS)
PFS is defined as the time from the date of enrollment to the date of disease progression or death from any cause, whichever occurs first. Patients without progression or death will be censored at the last date of tumor assessment.
Time frame
Up to 12 months2
Overall Survival (OS)
OS is defined as the time from the date of enrollment to the date of death from any cause. Patients alive at the time of analysis will be censored at the date of last follow-up.
Time frame
Up to 12 monthsOther outcomes
1
Incidence and Severity of Adverse Events
Safety will be assessed by the incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs), graded according to CTCAE version 5.0. Laboratory values, vital signs, ECOG performance status, and physical exams will also be monitored.
Time frame
From first dose to 30 days after last dose of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xi Junjie
Lead sponsor
Shanghai Zhongshan Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: