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

Phase 2

• Conditions: Esophageal Squamous Cell Carcinoma; Locally Advanced Carcinoma
• Interventions: Drug: Tislelizumab; Drug: 5-FU; Drug: cis Platinum

• Registration Number: NCT05469061
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-06-08
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-19
• Last Update Submitted: 2022-07-19
• Study First Posted: 2022-07-21
• Last Update Posted: 2022-07-21
• Primary Completion: 2022-08-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tislelizumab plus Chemotherapy	cis Platinum	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 .
Tislelizumab plus Chemotherapy	Tislelizumab	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 .
Tislelizumab plus Chemotherapy	5-FU	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 .

Primary Outcome Measures

Name	Time	Method
Incidence of translational treatment AE	up to 2 years	Translational treatment-related AEs resulted in rates of surgery that were more than 30 days late or inoperable than originally planned
MPR	up to 2 years	The proportion of patients whose primary tumor cell residual was less than 10% in the total number of patients enrolled after transformation therapy
pCR	up to 2 years	Pathological complete response refers to that no tumor component or a small amount of carcinoma in situ component can be found on the horizontal line of pathological section after systemic treatment and surgical resection of the lesion.

Secondary Outcome Measures

Name	Time	Method
Disease-free Survival，DFS	up to 2 years	The time from randomization to disease recurrence or death due to disease progression
R0 resection rate	up to 2 years	The proportion of patients who completed R0 resection through 3 cycles of immunotherapy combined with chemotherapy in the total enrolled population.R0 finger resection margin under microscope was negative.

Trial Locations

Locations (1)

Jiangsu Provincial People's Hospital; 🇨🇳 Nanjing, Jiangsu, China