PPIO-008 Tislelizumab Combined With S-1 in Patients With ypT+N0 ESCC After Radical Resection With Neoadjuvant STUDY

NCT06354140 | Recruiting Phase 2

• 1 other identifier: WeGuo
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the safety and efficacy of Tegafur combined with tislelizumab in patients with esophageal squamous cell carcinoma with residual primary lesion and node-negative after radical resection following neoadjuvant immunotherapy combined with chemotherapy

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

ypT1-4N0M0

Outcome Measures

Primary Outcomes (1)

• 1-year DFS rate

  Rate from surgical resection to local recurrence within one year

  Up to 12months

Secondary Outcomes (2)

• Overall survival

  Up to 24 months

• Progression-free survival

  Up to 24 months

Study Arms (1)

S-1 Combined With Tislelizumab

EXPERIMENTAL

tegafur (S-1) 80mg/100mg/120mg Q3W (discontinued at the third week) + tislelizumab 200 mg Q3W, treatment for 1 year. tegafur: body surface area (BSA) \< 1.25m2, use 80mg; 1.25-1.5m2, use 100mg; \> 1.5m2, use 120mg. Treatment for 1 year

Drug: Tegafur

Interventions

Tegafur DRUG

Tegafur (S-1) 80mg/100mg/120mg Q3W (discontinued at the third week) + tislelizumab 200 mg Q3W, treatment for 1 year. Tegafur: body surface area (BSA) \< 1.25m2, use 80mg; 1.25-1.5m2, use 100mg; \> 1.5m2, use 120mg. Treatment for 1 year

Also known as: tislelizumab

S-1 Combined With 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:

• Age 18-75 years old, gender is not limited;
• Patients with esophageal squamous cell carcinoma with neoadjuvant immunotherapy combined with chemotherapy (radiotherapy was not planned during the study period);
• Thoracic esophageal squamous cell carcinoma patients with residual pathologic primary site and lymph node positive (ypT1-4aN0M0) after surgery (8th UICC-TNM stage);
• The operation was radical resection;
• Physical status ECOG 0 \~ 1 score;
• No local recurrence or distant metastasis was found in the examination before postoperative adjuvant treatment;
• There were no contraindications of chemotherapy or immunotherapy in the evaluation of various organ functions;
• Understand and sign the informed consent.

You may not qualify if:

• Had malignant tumors other than esophageal cancer within 5 years prior to admission (cured localized tumors were not excluded, including cervical carcinoma in situ, skin basal cell carcinoma and prostate carcinoma in situ, etc.); Prostate cancer patients who received hormone therapy and obtained DFS for more than 5 years were not excluded).
• Prior history of interstitial lung disease, or pneumonia requiring steroid treatment when enrolled;
• Receiving systemic steroid therapy (more than 10mg of prednisone per day or equivalent) or other immunosuppressant within 2 weeks prior to randomization;
• People who have been severely allergic to chemotherapy drugs (fluorouracil) or any monoclonal antibody;
• Patients with active autoimmune diseases;
• Patients with active hepatitis
• According to the judgment of the researcher, there are other circumstances that are not suitable for participation in this study.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

Army Medical Center of the People's Liberation Army

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Tegafur; tislelizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Wei Guo

CONTACT

+86 13527323568; gyguowei@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: The study was a one-arm open study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)