Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma

NCT ID: NCT05515315

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2027-05-31

Brief Summary

To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of locally unresectable esophageal squamous cell carcinoma (ESCC)

Conditions

Immunotherapy Esophagus Cancer

Study Design

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

Study Groups

Tislelizumab combined with chemothapy

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks

Albumin paclitaxel

Intervention Type: DRUG

Participants will receive Albumin paclitaxel 260 mg/m2 , day 1 of every 3 weeks

Nedaplatin

Intervention Type: DRUG

Participants will receive Nedaplatin 80 mg/m2 , day 1 of every 3 weeks

radiotherapy

Intervention Type: RADIATION

50-60Gy/25-30f

Interventions

Tislelizumab

Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks

Intervention Type: DRUG

Albumin paclitaxel

Participants will receive Albumin paclitaxel 260 mg/m2 , day 1 of every 3 weeks

Intervention Type: DRUG

Nedaplatin

Participants will receive Nedaplatin 80 mg/m2 , day 1 of every 3 weeks

Intervention Type: DRUG

radiotherapy

50-60Gy/25-30f

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed localized ESCC that is suitable for cCRT, including: stage II-IVA (AJCC version 8) inoperable ESCC (medically unfit for surgery or refusing surgical intervention);;
• Aged 18-70, both sexes;
• ECOG score 0-1
• The presence of measurable and/or nonmeasurable lesions that met the definition of RECIST1.1;
• Adequate organ and bone marrow function, meeting the following definitions:

1. Blood routine (no blood transfusion, no granulocyte colony-stimulating factor [G-CSF], and no other drugs were used within 14 days before treatment);Absolute neutrophil count (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥100×109/L;

2. Blood biochemistry Creatinine clearance rate ≥60 mL/min;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;

• Expected survival time > 6 months;
• Fertile female subjects and male subjects with partners of reproductive age are required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last treatment;
• Patients who volunteered to participate in this study and signed the informed consent form.

Exclusion Criteria

• A history of fistula caused by primary tumor invasion;
• Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites that required repeated drainage or medical intervention (within 2 weeks before randomization);
• Known intolerance or resistance to chemotherapy specified in the trial protocol;
• have received any other ESCC antitumor therapy (e.g., therapy targeting PD-1, PD-L1, PD-L2 or other tumor immunotherapy, radiotherapy, targeted therapy, ablation or other systemic or local antitumor therapy);
• Patients with active autoimmune disease or a history of autoimmune disease that may relapse, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• History of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis and acute lung disease;
• Severe chronic or active infection (including tuberculosis infection) requiring systemic antimicrobial therapy, antifungal therapy or antiviral therapy before enrollment;
• Known history of HIV infection;
• Other malignancies (except cured basal cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix) in the past 5 years;
• Received live vaccine within 28 days before enrollment;
• while participating in another therapeutic clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fuzhou General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ye zai sheng

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fu zhi chao, Doctor of Medicine

Role: CONTACT

fauster1112@126.com

13774562945 ext. 86

Facility Contacts

Fu zhi chao, doctor

Role: primary

fauster1112@126.com

13774562945 ext. 86

Other Identifiers

TPT-ESCC

Identifier Type: -

Identifier Source: org_study_id