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Neoadjuvant Cardonilizumab Combined With Neoadjuvant Chemoradiotherapy Can Resect Locally Advanced Esophageal Squamous Cell Carcinoma

NCT07699185 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2026-07-13

No results posted yet for this study

Summary

This is a multicenter, open-label, randomized, controlled clinical study to compare the efficacy and safety of cardonilizumab combined with neoadjuvant chemotherapy and surgery versus neoadjuvant chemoradiotherapy and surgery in locally advanced ESCC. Subjects were randomly divided into experimental group and control group, the experimental group received neoadjuvant immunotherapy concurrent chemotherapy regimen, the control group received neoadjuvant concurrent chemoradiotherapy regimen, and then received McKeown surgery. The primary outcome measures were complete pathological response (pCR), and the secondary outcome measures were major pathological response (MPR), EFS (event-free survival), OS (overall survival), overall response rate (ORR), decreased pathological stage, R0 resection rate, adverse events (AE), and perioperative complications

Conditions

Interventions

BIOLOGICAL

Cardonilizumab

Cardonilizumab 10 mg/kg, once every 3 weeks, will be administered intravenously as an infusion of 120 minutes (±10 minutes). The investigator continuously monitors potential infusion responses and pretreats hypersensitivity reactions and/or adjusts the infusion rate as recommended by the protocol. For subjects who cannot tolerate a 120-minute infusion, the infusion time can be extended to a maximum of 240 minutes. Within 72 hours prior to each dosing, subjects were required to complete a series of tests including vital signs, physical examination, laboratory tests, and fitness status scores to assess the safety and tolerability of continued treatment

DRUG

Paclitaxel

paclitaxel 135mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery

DRUG

Cisplatin

Cisplatin 80mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery

RADIATION

neoadjuvant chemoradiotherapy

Radiotherapy: 40 Gy (2Gy×20 times), 5 times/week for 5 consecutive weeks; Chemotherapy: paclitaxel 50mg/m2+ cisplatin 25mg/m2 once a week for 4 weeks

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07699185 on ClinicalTrials.gov