Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced ESCC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorShandong Provincial Hospital
About this trial
This is a single-arm, single-center, open-label, observational clinical study. A total of 30 patients with initially unresectable locally advanced esophageal squamous cell carcinoma will be enrolled.Eligible patients will receive albumin-bound paclitaxel (260 mg/m², day 1, every 3 weeks \[Q3W\]) plus cisplatin (75 mg/m²) or carboplatin (AUC = 5), in combination with tislelizumab (200 mg, day 2, Q3W), for 2-4 cycles. Tumor staging will be reassessed thereafter, and the feasibility of surgical resection will be determined based on multidisciplinary team (MDT) discussion.The primary endpoint is the conversion rate to surgery.
Secondary endpoints include pathological complete response (pCR), objective response rate (ORR), and safety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent is obtained prior to any study-related procedures.
Age 18 to 75 years, inclusive; both male and female patients are eligible.
No evidence of distant metastasis.
At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Disqualifiers
Prior receipt of radiotherapy, chemotherapy, hormonal therapy, surgery, or molecular targeted therapy for esophageal cancer.
Evidence of distant metastasis confirmed by imaging.
History of other malignancies, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
Prior treatment with any anti-PD-1 or anti-PD-L1 agents; known hypersensitivity to monoclonal antibodies or any component of tislelizumab.
Trial population
Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tislelizumab Plus Chemotherapy
Drugalbumin-bound paclitaxel (260 mg/m², day 1, every 3 weeks \[Q3W\]) plus cisplatin (75 mg/m²) or carboplatin (AUC = 5), in combination with tislelizumab (200 mg, day 2, Q3W), for 2-4 cycles
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Tislelizumab Plus Chemotherapy1 intervention
Trial outcomes
Primary outcomes
1
Conversion Surgery Rate
Defined as the proportion of patients with initially unresectable locally advanced esophageal squamous cell carcinoma who become eligible for curative-intent surgical resection after study treatment, as determined by multidisciplinary team (MDT) assessment.
Time frame
Up to 12 weeks after initiation of treatment (after completion of 2-4 treatment cyclesSecondary outcomes
1
Pathological Complete Response (pCR) Rate
pCR is defined as the absence of residual viable tumor cells in both the primary tumor and regional lymph nodes (ypT0N0)
Time frame
At the time of surgery, approximately 8-16 weeks after initiation of study treatment.2
Objective Response Rate (ORR)
ORR is defined as the proportion of patients achieving a best overall response of complete response (CR) or partial response (PR).
Time frame
From baseline to completion of 2-4 cycles of treatment (approximately 6-12 weeks), at post-treatment tumor assessment.3
Incidence of Treatment-Related Adverse Events (TRAEs)
TRAEs are defined as adverse events considered by investigators to be related to study treatment.
Time frame
From the first dose of study treatment up to 30 days after the last dose of study treatment.Sponsors and contacts
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Source ClinicalTrials.gov