Combining Tislelizumab with chemotherapy for treating inoperable esophageal cancer

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

This study is testing if combining the immunotherapy drug Tislelizumab with chemotherapy can help people with inoperable esophageal cancer feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fuzhou General Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Tislelizumab
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT05515315 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Tislelizumab, an immunotherapy drug, in combination with chemotherapy agents such as Albumin paclitaxel and Nedaplatin, followed by definitive chemoradiotherapy for patients with locally unresectable esophageal squamous cell carcinoma (ESCC). The study aims to determine how well this treatment approach works for patients who are not candidates for surgery due to the stage of their cancer. Participants will be closely monitored for their response to the treatment and any side effects experienced during the process.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 with histologically confirmed localized ESCC that is inoperable and suitable for chemoradiotherapy.

Not a fit: Patients with resectable esophageal cancer or those who are not medically fit for chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with locally unresectable esophageal cancer, potentially improving survival rates.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy and chemotherapy combinations in treating esophageal cancer, suggesting potential for success in this approach.

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.

Where this trial is running

Fuzhou, Fujian

• Ye zai sheng — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Fu zhi chao, Doctor of Medicine

Conditions Immunotherapy Esophagus Cancer