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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

The Safety and Efficacy of Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC，A Single-arm Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05469061
• Other study ID #: 2021-SR-372
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: July 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Tongpeng Xu, PhD
• Phone: 18915594572
• Email: tongpeng_xu_njmu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: November 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Tislelizumab
The 1st to 3rd doses were administered concurrently with FP regimen chemotherapy, 200 mg Tislelizumab each, on D1, D22 and D43 by intravenous infusion. In patients with successful conversion, one dose of 200 mg was administered 21 days after surgery in concurrent with the 4th to 6th cycles of 5-Fu, then 6 cycles of 200 mg Tislelizumab as adjuvant therapy; in patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.
• 5-FU
A FP regimen with 5-Fu 850mg/m^2 d1-4 + cis-platinum 850mg/m^2 d1-4 was used, on D1, D22 and D43 infused intravenously. 3 cycles of 5-Fu 850mg/m^2 d1-4 adjuvant chemotherapy were started at 21 days after surgery in patients with a successful conversion. In patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.
• cis Platinum
A FP regimen with 5-Fu 850mg/m^2 d1-4 + cis-platinum 850mg/m^2 d1-4 was used, on D1, D22 and D43 infused intravenously. In patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.

Locations

Country	Name	City	State
China	Jiangsu Provincial People's Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of translational treatment AE	Translational treatment-related AEs resulted in rates of surgery that were more than 30 days late or inoperable than originally planned	up to 2 years
Primary	MPR	The proportion of patients whose primary tumor cell residual was less than 10% in the total number of patients enrolled after transformation therapy	up to 2 years
Primary	pCR	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.	up to 2 years
Secondary	R0 resection rate	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.	up to 2 years
Secondary	Disease-free Survival,DFS	The time from randomization to disease recurrence or death due to disease progression	up to 2 years