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
Qualifiers
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 design
Treatments tested in this trial
- Tislelizumab Plus Chemotherapy
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov