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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma Locally Advanced Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tislelizumab plus Chemotherapy

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 .

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes