Tislelizumab Combined With Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma Followed by CRT or Surgery

NCT07046221 | Not Yet Recruiting Phase 2

• 1 other identifier: EC-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

To explore the non-inferiority of the 2y-OS rate of tislelizumab combined with chemotherapy after sequential CRT in the treatment of resectable esophageal squamous cell carcinoma compared with the surgical group

Conditions

Esophagus Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival rate of 2 years

  The proportion of patients who were still alive from the start of randomization (or the start of treatment in a single-arm trial) to 2 years

  2 years

Secondary Outcomes (1)

• objective response rate

  every 2 weeks until 3 years

Study Arms (2)

CRT+Tislelizumab

EXPERIMENTAL

RT：50.5Gy/28f albumin-bound paclitaxel：125mg/m2，d1，d8，q3w，2cycles cis-platinum：75mg/m2，d1，q3w，2cycles/carboplatin：AUC=5，d1，q3w，2 cycles/Nedaplatin：80-100mg/m2，d1，q3w，2 cycles Tislelizumab: 200mg，d1，q3w，1years

Drug: Tislelizumab; Drug: Albumin-Bound Paclitaxel; Drug: cis-platinum; Radiation: Radiation; Drug: Nedaplatin; Drug: Carboplatin

surgery+Tislelizumab

EXPERIMENTAL

Radical resection of esophageal cancer Tislelizumab: 200mg，d1，q3w，1years

Drug: Tislelizumab; Procedure: Surgery

Interventions

Tislelizumab DRUG

200mg，d1，q3w，1years

CRT+Tislelizumab; surgery+Tislelizumab

Albumin-Bound Paclitaxel DRUG

125mg/m2，d1，d8，q3w，2cycles

CRT+Tislelizumab

cis-platinum DRUG

75mg/m2，d1，q3w，2cycles

CRT+Tislelizumab

Surgery PROCEDURE

Radical resection of esophageal cancer

surgery+Tislelizumab

Radiation RADIATION

50.5Gy/28f

CRT+Tislelizumab

Nedaplatin DRUG

80-100mg/m2，d1，q3w，2cycles

CRT+Tislelizumab

Carboplatin DRUG

AUC=5，d1，q3w，2cycles

CRT+Tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects were included in this study and signed the informed consent form.
• Male or female patients aged between 18 and 75 years old;
• Patients diagnosed with esophageal squamous cell carcinoma by histopathology;
• According to the 8th edition of the AJCC Esophageal cancer TNM staging system, it is located in cT2N+ or cT3-4aNanyM0 (confirmed by enhanced CT/MRI of the chest and abdomen), and the lesion is located in the thoracic segment.
• ECOG score: 0-1.
• The main organs function normally, that is, they meet the following standards:
• Blood routine (no blood transfusion was performed within 14 days before treatment, no granulocyte colony-stimulating factor \[G-CSF\] was used, and no other drugs were used for correction);
• The absolute neutrophil count (ANC) was ≥1.5×109/L;
• Hemoglobin (HB) ≥9.0 g/dL;
• Platelet count (PLT) ≥100×109/L;
• Blood biochemistry
• Creatinine clearance rate ≥60 mL/min;
• Total bilirubin (TBIL) ≤ 1.5×ULN;
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;
• The expected survival period is ≥3 months;

You may not qualify if:

• There are clinically uncontrolled pleural effusions, pericardial effusions or ascites that require repeated drainage or medical intervention (within 2 weeks before randomization);
• It is known that there is intolerance or resistance to the chemotherapy specified in the trial protocol;
• Have received any other ESCC anti-tumor treatments (e.g., targeted treatments for PD-1, PD-L1, PD-L2, or other tumor immunotherapy, radiotherapy, targeted therapy, ablation, or other systemic or local anti-tumor treatments);
• Patients with active autoimmune diseases or a history of autoimmune diseases that may recur, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Have a history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis, acute lung diseases, etc.
• Before enrollment, there was a severe chronic or active infection (including tuberculosis infection, etc.) that required systemic antibacterial, antifungal or antiviral treatment;
• A known history of HIV infection;
• Having suffered from other malignant tumors within the past five years (excluding cured basal cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix);
• Have received live vaccines within 28 days before enrollment;
• Participated in other therapeutic clinical trials within 4 weeks;
• Distant metastasis exists (except for supraclavicular lymph nodes).

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

tislelizumab; Albumin-Bound Paclitaxel; Cisplatin; Surgical Procedures, Operative; Radiation; nedaplatin; Carboplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena; Coordination Complexes

Central Study Contacts

Chen jun qiang, bachelor

CONTACT

13705036281; junqiangc@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: July 1, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2030
• Last Updated: July 20, 2025

Record last verified: 2025-06