To hear about similar clinical trials, please enter your email below
Trial Title:
Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma
NCT ID:
NCT05515315
Condition:
Immunotherapy Esophagus Cancer
Conditions: Official terms:
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Esophageal Neoplasms
Paclitaxel
Tislelizumab
Nedaplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1
of every 3 weeks
Arm group label:
Tislelizumab combined with chemothapy
Intervention type:
Drug
Intervention name:
Albumin paclitaxel
Description:
Participants will receive Albumin paclitaxel 260 mg/m2 , day 1 of every 3 weeks
Arm group label:
Tislelizumab combined with chemothapy
Intervention type:
Drug
Intervention name:
Nedaplatin
Description:
Participants will receive Nedaplatin 80 mg/m2 , day 1 of every 3 weeks
Arm group label:
Tislelizumab combined with chemothapy
Intervention type:
Radiation
Intervention name:
radiotherapy
Description:
50-60Gy/25-30f
Arm group label:
Tislelizumab combined with chemothapy
Summary:
To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of
locally unresectable esophageal squamous cell carcinoma (ESCC)
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ye zai sheng
Address:
City:
Fuzhou
Zip:
350500
Country:
China
Status:
Recruiting
Contact:
Last name:
Fu zhi chao, doctor
Phone:
13774562945
Phone ext:
86
Email:
fauster1112@126.com
Start date:
May 31, 2022
Completion date:
May 31, 2027
Lead sponsor:
Agency:
Fuzhou General Hospital
Agency class:
Other
Source:
Fuzhou General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05515315