A Prospective, Randomized, Controlled, Single-center Phase II Clinical Trial of Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy for Locally Advanced Esophageal Cancer.

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

This study is a double-arm, randomized, controlled, single-center, phase II clinical trial aimed at evaluating the efficacy and safety of chemoradiotherapy plus immunotherapy with or without Trilaciclib in the treatment of locally advanced esophageal squamous cell carcinoma that is not resectable.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients voluntarily participated in this study, signed the informed consent form, and had good compliance;

• Age ≥ 18 years old, male or female;

• Patients with histologically confirmed locally advanced esophageal squamous cell carcinoma at stage II-IV that is unresectable, or where surgery is contraindicated or refused (according to the AJCC 8th edition, the clinical stage before treatment was: cT1N2-3M0, cT2-4bN0-3M0, M1 limited to non-regional lymph node metastasis, excluding distant organ metastasis);

• The presence of at least one measurable lesion according to the response evaluation criteria in solid Tumors (RECIST1.1);

• Have not received any systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted drug therapy, immunotherapy, biological therapy, local therapy, and other investigational therapeutic drugs);

• ECOG: 0-1 ;

• Expected survival time ≥ 6 months;

• Vital organ function meets the following requirements (no blood components and cell growth factors are allowed for 2 weeks before the start of screening examination) :Absolute neutrophil count (ANC) ≥1.5×109/L;Platelet count ≥100×109/L;Hemoglobin ≥100 g/L in women or 110g/L in men;Serum albumin ≥2.8g/dL;Total bilirubin ≤1.5 × ULN and ALT, AST, and/or AKP≤2.5 × ULN

• , serum creatinine 1.5 x ULN or creatinine clearance or greater or less 60 ml/min (according to Cockcroft - Gault formula);

• International standardization ratio (INR) and part activated clotting time (APTT) live enzymes acuities were 1.5 x ULN (for the use of stable doses of anticoagulants such as: low molecular heparin or warfarin and INR within the scope of the expected treatment of anticoagulants can filter);

• Women: All women of childbearing potential must have a negative serum pregnancy test at screening and must be using reliable contraception from written informed consent until 3 months after last dose.

Locations
Other Locations
China
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Xiaolin Ge, PHD
doctorsxl@163.com
83714511
Time Frame
Start Date: 2024-07-09
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 60
Treatments
Experimental: Experimental group
Trilaciclib 240mg/m2;Radiation therapy:50.4Gy/28/1.8;Paclitaxel: 135mg/m2, d1, Q3W, 4 cycles;Carboplatin: AUC=5, d2, Q3W, 4 cycles(or nedaplatin 75 mg/m2, d2, Q3W, 4 cycles);Immune inhibitors (by choice) : d1, Q3W, treatment + maintain phase, continuous dosing, until disease progression or not tolerated toxicity.
Sham_comparator: Control group
Radiation therapy:50.4Gy/28/1.8;Paclitaxel: 135mg/m2, d1, Q3W, 4 cycles;Carboplatin: AUC=5, d2, Q3W, 4 cycles(or nedaplatin 75 mg/m2, d2, Q3W, 4 cycles);Immune inhibitors (by choice) : d1, Q3W, treatment + maintain phase, continuous dosing, until disease progression or not tolerated toxicity.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov