Neoadjuvant Immunotherapy Plus Chemotherapy and Anlotinib Versus Immunotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced ESCC

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The goal of this interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Surgically resectable cT1-4aN+M0 or cT3-4aN0M0 esophageal squamous cell carcinoma initially diagnosed by histology or cytology

• Patients who can take anlotinib capsules orally

• No previous systematic antitumor treatment

• ECOG PS 0-1

• The function of important organs meets the following requirements: absolute neutrophil count≥1.5×10\^9 / L; platelet≥80×10\^9 / L; hemoglobin≥80×10\^9 / L; total bilirubin≤1.5×upper limit of normal; within normal serum creatinine; ALT and glutamatergic aminase≤2.5× upper limit of normal

• No incurable serious complications or other major diseases

• The thoracic surgeon judges that the operation can be tolerated

• Female subjects with fertility, and male subjects with childbearing partners, required a medically approved contraceptive during study treatment and at least 6 months after the last chemotherapy

• The subjects volunteered to join the study, signed informed consent, had good compliance and cooperated with follow-up

Locations
Other Locations
China
Army Medical Center of PLA
RECRUITING
Chongqing
Contact Information
Primary
Mengxia Li
mengxia.li@outlook.com
86-18580408265
Backup
Xiao Yang
yangxiao625@outlook.com
86-19923257675
Time Frame
Start Date: 2024-03-08
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 266
Treatments
Experimental: neoadjuvant immunotherapy plus chemotherapy and anlotinib
neoadjuvant immunotherapy plus chemotherapy and anlotinib
Experimental: neoadjuvant immunotherapy combined with concurrent chemoradiotherapy
neoadjuvant immunotherapy combined with concurrent chemoradiotherapy
Related Therapeutic Areas
Sponsors
Leads: Army Medical Center of PLA

This content was sourced from clinicaltrials.gov

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