Clinical trial NCT05515315: Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma
Official title: Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Immunotherapy Esophagus Cancer
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: progression free survival
timeFrame: up to 24 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: every 6 weeks （up to 24 months）
measure: Overall survival (OS)
timeFrame: every 3 months (up to 24 months)
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Ye zai sheng
state: Fujian
Study officials:
References: