Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC

Nanjing Medical University

Status and phase: Enrolling; Phase 2

Conditions: Locally Advanced Carcinoma; Esophageal Squamous Cell Carcinoma

Treatments: Drug: cis Platinum; Drug: Tislelizumab; Drug: 5-FU

Study type: Interventional

Funder types: Other

Identifiers

NCT05469061

2021-SR-372

Details and patient eligibility

About

This is a single-arm，open-label study to evaluate the efficacy and safety of tislelizumab plus chemotherapy for conversion therapy of patients with locally nonresectable ESCC.

Enrollment: 17 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Aged between 18 and 75 years;
2. Understand the research procedure and content, and voluntarily sign written informed consent;
3. Patients with clinical stage IIA-IIIB esophageal cancer were assessed by endoscopic ultrasonography, CT/MRI and other imaging.
4. Esophageal surgery experts believe that patients with potentially resectable esophageal cancer
5. No blood transfusion was received 3 months before enrollment;
6. ECOG PS score: 0-1.

Exclusion criteria

• Patients meeting any of the following criteria are not eligible for inclusion:

  1. Women who are pregnant or breastfeeding;
  2. previous or concurrent malignancy;
  3. Participated in clinical trials of other drugs within four weeks;
  4. Have a history of immune deficiency, or other acquired or congenital immune deficiency diseases, or have a history of organ transplantation, or have a history of serious chronic autoimmune diseases, such as systemic lupus erythematosus, etc.
  5. Patients with hypersensitivity to human or mouse monoclonal antibodies;
  6. Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders;
  7. According to the judgment of the researcher, there are serious concomitant diseases that endanger the patient's safety or affect the patient's ability to complete the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Tislelizumab plus Chemotherapy

Experimental group

Description:

In the single experimental arm, patients with locally nonresectable disease were subjected to receive neoadjuvant tislelizumab (200mg) plus chemotherapy (FP regimen) for conversion therapy. If conversion therapy succeeds, patients would proceed to surgery and adjuvant therapy. Otherwise, if patients were still not resectable after the conversion therapy, they will be treated by tislelizumab plus chemotherapy with or without palliative radiotherapy .

Treatment:

Drug: cis Platinum

Drug: Tislelizumab

Drug: 5-FU