Safety and efficacy of Tirelizumab combined with chemotherapy in neoadjuvant treatment of locally advanced intrathoracic esophageal squamous carcinoma

Safety and efficacy of Tirelizumab combined with chemotherapy in neoadjuvant treatment of locally advanced intrathoracic esophageal squamous carcinoma——A prospective two-cohort study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300073320

Enrollment

Unknown

Registered

2023-07-06

Start date

2022-01-01

Completion date

Unknown

Last updated

2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal squamous cancer

Interventions

Albumin-paclitaxel group:Neoadjuvant immunotherapy plus chemotherapy(Tirelizumab + albumin-paclitaxel + platinum-based drugs) before surgery

Paclitaxel group:Neoadjuvant immunotherapy plus chemotherapy(Tirelizumab + paclitaxel + platinum-based drugs) before surgery

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Patients who sign informed consent and are willing to complete the study according to the plan; 2) Age 18-75 years old; 3) ECOG score: 0-1; 4) No lung, liver, pelvic, peritoneum and other distant organ metastasis. ; 5) Esophageal squamous cell carcinoma was confirmed by histology; 6) Endothoracic esophageal carcinoma was evaluated by gastroscopy (22-40cm) and GI; 7) Preoperative CT and endoscopic ultrasonography were evaluated as patients with completely resectable thoracic esophageal cancer (T1-2N1-2M0, T3-4aN0-3M0); The preoperative surgical treatment group discussed that R0 resection could be achieved; Preoperative B-ultrasound and CT were used to evaluate no suspicious metastatic lymph nodes (diameter 4 000/mm3 Neutrophil =2 000/mm3 Hemoglobin > 10.0g/dL Platelet > 60 000/mm3 Liver function: bilirubin 0.6L, MVV>35%; 9) Cardiovascular system: no myocardial infarction in the past 6 months; No symptomatic cardiovascular disease.

Exclusion criteria

Exclusion criteria: 1) Previous history of other tumors; 2) Previous neck; History of thoracic and abdominal surgery 3) Infected persons with immune deficiency and AIDS; 4) severe insufficiency of heart, lung, liver and kidney; 5) Uncontrolled or active infections; 6) Pregnant and lactating women; 7) Previous history of immunotherapy, radiotherapy and chemotherapy.

Design outcomes

Primary

Measure	Time frame
Major pathological response (MPR);	—

Secondary

Measure	Time frame
Pathological complete response (PCR);R0 resection rate;Overall survival (OS);Disease-free survival (DFS);Safety;	—

Countries

China

Contacts

Public ContactSun Yihua

Shanghai Cancer Hospital Affiliated to Fudan University

11307120136@fudan.edu.cn+86 181 2129 7568

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026