Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced ESCC

Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

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.

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Tislelizumab Plus Chemotherapy

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: ALei Feng; Phone Number: +8613402214659; Email: 370100668@qq.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • Shandong Provincial Hospital
      • Contact: ALei Feng; Phone Number: +8613402214659; Email: 370100668@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

Description

Inclusion Criteria:

1. Written informed consent is obtained prior to any study-related procedures.
2. Age 18 to 75 years, inclusive; both male and female patients are eligible.

3. Histologically and radiologically confirmed thoracic esophageal squamous cell carcinoma (ESCC) with initially unresectable locally advanced disease, defined as:

   T4b tumors invading adjacent critical structures, including the heart, great vessels, trachea, or other adjacent organs (including liver, pancreas, lung, or spleen); or Multiple-station or bulky lymph node metastases.

4. No evidence of distant metastasis.
5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
7. Estimated life expectancy of ≥6 months.

8. Adequate organ function, as defined below (without transfusion of blood products or use of hematopoietic growth factors within 14 days prior to assessment):

   Hematologic function: absolute neutrophil count (ANC) ≥1,500/mm³; platelet count ≥100,000/mm³; hemoglobin ≥9 g/dL (5.6 mmol/L).

   Renal function: serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥60 mL/min.

   Hepatic function: total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤1.5 × ULN.

9. For women of childbearing potential: must have a negative serum or urine pregnancy test within 7 days prior to enrollment, must not be breastfeeding, and must agree to use a medically acceptable method of contraception (e.g., intrauterine device, oral contraceptives, or barrier methods) during the study treatment period and for at least 3 months after the last dose.

   For men with partners of childbearing potential: must agree to use a medically acceptable method of contraception during the study treatment period and for at least 3 months after the last dose.

10. Willingness to participate in the study, good compliance, and ability to adhere to study procedures, including safety and survival follow-up.

Exclusion Criteria:

1. Prior receipt of radiotherapy, chemotherapy, hormonal therapy, surgery, or molecular targeted therapy for esophageal cancer.
2. Evidence of distant metastasis confirmed by imaging.
3. History of other malignancies, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
4. Prior treatment with any anti-PD-1 or anti-PD-L1 agents; known hypersensitivity to monoclonal antibodies or any component of tislelizumab.
5. Active autoimmune disease or a history of autoimmune disease, including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism.
6. Patients with vitiligo or a history of childhood asthma that has completely resolved and requires no intervention in adulthood may be eligible.
7. Patients with asthma requiring bronchodilator therapy are not eligible.

8. Current use of immunosuppressive medications, including systemic corticosteroids or absorbable local steroids for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment.

   Clinically significant ascites or pleural effusion requiring therapeutic drainage.

   Uncontrolled or clinically significant cardiovascular disease, including but not limited to:

   New York Heart Association (NYHA) class II or higher heart failure; Unstable angina; Myocardial infarction within 1 year prior to enrollment; Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.

9. Coagulation abnormalities, defined as: prothrombin time (PT) >16 seconds, activated partial thromboplastin time (APTT) >43 seconds, thrombin time (TT) >21 seconds, or fibrinogen (Fbg) >2 g/L; or presence of bleeding tendency, or ongoing thrombolytic or anticoagulant therapy.
10. Presence of gastrointestinal conditions associated with a high risk of bleeding or perforation within 3 months prior to enrollment, including but not limited to esophageal varices, active gastric or duodenal ulcers, ulcerative colitis, portal hypertension, or unresected tumors with active bleeding; or any other condition judged by the investigator to pose a risk of gastrointestinal bleeding or perforation.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tislelizumab Plus Chemotherapy; Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma	Drug: Tislelizumab Plus Chemotherapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 weeks after initiation of treatment (after completion of 2-4 treatment cycles

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	At the time of surgery, approximately 8-16 weeks after initiation of study treatment.
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).	From baseline to completion of 2-4 cycles of treatment (approximately 6-12 weeks), at post-treatment tumor assessment.
Incidence of Treatment-Related Adverse Events (TRAEs)	TRAEs are defined as adverse events considered by investigators to be related to study treatment.	From the first dose of study treatment up to 30 days after the last dose of study treatment.

Collaborators and Investigators

• Sponsor: Shandong Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Therapy; tislelizumab
• Other Study ID Numbers: SWYX:NO.2023-1029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No