Conversion of Tislelizumab Combined With Chemotherapy in Unresectable Esophageal Squamous Cell Carcinoma

NCT ID: NCT05449483

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2025-06-30

Brief Summary

Whether the introduction of immunotherapy can transform unresectable esophageal cancer into resectable, or even achieve R0 surgical resection, has not been reported yet. We plan to conduct a prospective, single-center, single-arm phase II clinical study of the safety and efficacy of tislelizumab combined with chemotherapy in the treatment of unresectable esophageal squamous cell carcinoma.

Detailed Description

For patients not eligible for R0 resection (defined as locally advanced unresectable esophageal cancer), preoperative treatment can theoretically transform the tumor into a resectable state. The current significance of transformation therapy is to reduce tumor volume and stage to achieve radical resection, eliminate micrometastases, and prevent a postoperative recurrence. There are few studies on the transformation therapy of esophageal squamous cell carcinoma. We plan to conduct a prospective, single-center, single-arm phase II clinical study of the safety and efficacy of tislelizumab combined with chemotherapy in the treatment of T4a/N3 esophageal squamous cell carcinoma.

Conditions

Esophageal Squamous Cell Carcinoma by AJCC V8 Stage; Unresectable

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tislelizumab+ Paclitaxel+Cisplatin

Paclitaxel 135mg/m2 , D1; Cisplatin 80mg/m2, D1; tislelizumab 200mg D2 ; totally 2-4 cycles

Group Type: EXPERIMENTAL

tislelizumab+ Paclitaxel + Cisplatin

Intervention Type: DRUG

tislelizumab combined with chemotherapy

Interventions

tislelizumab+ Paclitaxel + Cisplatin

tislelizumab combined with chemotherapy

Intervention Type: DRUG

Other Intervention Names

conversion therapy

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed esophageal squamous cell carcinoma;

2. Unresectable cT4a/N3(stage ⅣA) (AJCC 8 TNM classification);

3. Have a performance status of 0 or 1 on the ECOG Performance Scale;

4. Age 18-75 years old, both men and women;

5. Be willing and able to provide written informed consent/assent for the trial;

6. Demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation;

7. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours before receiving the study medication's first dose. If the urine test is positive or cannot be confirmed as unfavorable, a serum pregnancy test will be required;

8. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly acquired is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.

Exclusion Criteria

1. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer;

2. Ineligibility or contraindication for esophagectomy;

3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;

4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs);

5. Has severe hypersensitivity and adverse events (≥Grade 3) to any PD-1/PD-L1 inhibitors.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongjing Jiang, MD，phD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

Hongjing Jiang

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongjing Jiang, MD，phD

Role: CONTACT

jianghongjing@tmu.edu.cn

18622221069

Xiaobin Shang, MD，phD

Role: CONTACT

shangxiaobin@tmu.edu.cn

18622221071

Facility Contacts

Hongjing Jiang, MD,PhD

Role: primary

jianghongjing@tmu.edu.cn

18622221069

xiaobin shang, MD,PhD

Role: backup

shangxiaobin@tmu.edu.cn

18622221071

Other Identifiers

E20220333A

Identifier Type: -

Identifier Source: org_study_id