Tislelizumab Combined With Concurrent Chemoradiation Versus Concurrent Chemoradiation for Older Patients With Inoperable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Parallel-controlled, Multicenter Phase II Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study was conducted in elderly (≥70 years old) patients with locally advanced esophageal squamous cell carcinoma. Aim to find the difference in efficacy and safety between tirilizumab combined with concurrent chemoradiation and standard concurrent chemoradiation. Concurrent chemoradiation is the standard treatment for elderly esophageal cancer. Tirelizumab is the first-line and second-line standard treatment for advanced esophageal squamous carcinoma. However, the effect of tirilizumab combined with concurrent chemoradiation for elder with locally advanced esophageal squamous cell carcinoma is unkown. In the study, the investigators plan to enroll 136 elderly subjects with locally advanced esophageal cancer from five hospitals in China. The enrolled patients will be randomly divided into two groups: tirilizumab combined with concurrent chemoradiation group (Tislelizumab + radiotherapy + tigio) and concurrent chemoradiation group (radiotherapy + tigio). The treatment efficiency and safety will be evaluated.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Maximum Age: 90
Healthy Volunteers: f
View:

• Volunteered to participate, cooperated with follow-up visits;

• Aged ≥ 70 years, both male and female;

• Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1(supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC );

• Clinically staged as II-IVb inoperable locally advanced ESCC(including non-resectable, or with contraindications to or refusal of surgery);

• ECOG performance status 0 or 1;

• Presence of measurable and/or non-measurable lesions as defined by RECIST 1.1;

• Haven't received any previous systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecularly targeted drug therapy, immunotherapy, biologic therapy, topical therapy and other investigational therapeutic agents);

• Provide fresh or archived tumour tissue samples within 6 months (fresh samples preferred) for biomarker analysis (e.g.PD-L1). Sample types are formalin-fixed, paraffin-embedded \[FFPE\] tumour tissue blocks or at least 5 unstained, 3-5 μm thick FFPE tumour tissue sections;

• Expected survival ≥ 3 months;

⁃ Adequate hematologic function, defined as ANC ≥1500/μl, platelet count ≥100,000/μl and hemoglobin count ≥9.0 g/dl or ≥5.6 mmol/l;

⁃ Adequate renal function, defined as creatinine ≤1.5× ULN or measured or calculated creatinine clearance ≥60 mL/min for those with creatinine levels \>1.5× ULN (Calculated from the Cockcroft-Gault formula);

⁃ Adequate hepatic function, defined as total bilirubin ≤1.5× ULN and ALT/AST/AKP levels ≤2.5× ULN and albumin ≥2.8 g/dl;

⁃ Adequate coagulation function, defined as INR ≤1.5× ULN and APTT≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as INR is within the therapeutic range;

⁃ Documented informed consent.

Locations
Other Locations
China
Tianjin Cancer Hospital
RECRUITING
Tianjin
Contact Information
Primary
Wencheng Zhang, M.D.
zhangwencheng@tjmuch.com
02223340123
Backup
Ke Zhang, M.D
zk110105@163.com
02223340123
Time Frame
Start Date: 2023-10-05
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 136
Treatments
Experimental: Arm A
Tislelizumab + S1 + Radiotherapy Drug: Tirellizumab IV infusion,200 mg/3w, for 1 year~Drug: S1 PO, 40\~60mg,BID(d1-14,d22-35,two cycles)~Radiation: Radiation Concurrent Radiation, 1.8Gy/f, 28f
Active_comparator: Arm B
S1 + Radiotherapy~Drug: S1 PO, 40\~60mg,BID(d1-14,d22-35,two cycles)~Radiation: Radiation Concurrent Radiation, 1.8Gy/f, 28f
Related Therapeutic Areas
Sponsors
Collaborators: Shanxi Province Cancer Hospital, Hunan Cancer Hospital, Sichuan Cancer Hospital and Research Institute, Henan Cancer Hospital, The First Affiliated Hospital with Nanjing Medical University
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov