RecruitingPhase 2NCT06421376

Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer

Efficacy and Safety of Inductive Chemoimmunotherapy Followed by Chemoradiotherapy With or Without Surgery in Locally Advanced Esophageal Squamous Cell Cancer: a Single-arm, Prospective, Phase II Trial


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

60 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Although unprecedented advances have been made in the field of esophageal cancer in recent decades, the prognosis for patients with locally advanced esophageal squamous cell carcinoma (ESCC) remains extremely poor, accounting for 30-40% of overall survival at 5 year. In recent years, multimodal treatments have proven to be an appropriate therapeutic approach for locally advanced ESCC. Recently, immunotherapy developed rapidly. The purpose of this study was to observe the efficacy and safety of cardonilizumab combined with chemoradiotherapy in the treatment of locally advanced ESCC.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination approach for locally advanced esophageal (food pipe) cancer: chemotherapy plus immunotherapy given first, followed by chemoradiation (combined chemotherapy and radiation therapy). The goal is to shrink the tumor as much as possible before or instead of surgery. **You may be eligible if...** - You are aged 18–80 with confirmed esophageal squamous cell carcinoma (a specific cancer type) - Your cancer is locally advanced but has not spread to distant organs (or only to nearby lymph nodes above the collarbone) - You are in good overall health (ECOG 0–1) with normal blood counts and organ function - You have not had prior chemotherapy or radiation for this cancer **You may NOT be eligible if...** - Your cancer has spread far beyond the esophagus - You have significant organ problems (heart, lungs, kidneys, liver) - You are pregnant or breastfeeding - You have an active autoimmune condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCardonilizumab

Two cycles of Inductive therapy: nab-paclitaxel 250mg/ m2+cisplatin 75mg/ m2+Cardonilizumab 10mg/kg,ivgtt,3 weeks per cycle for 2 cycles

RADIATIONChemoradiotherapy ±immunotherapy

Chemoradiotherapy ± immunotherapy: * PTV: 50-50.4Gy/1.8-2Gy/25-28fractions ②nab-paclitaxel 100mg+cisplatin 25mg/ m2, d1, every 7 days for 3-5 weeks ③Cardonilizumab 10mg/kg,ivgtt,3 weeks per cycle for 2 cycles

PROCEDURERadical surgery

Surgery was evaluated after concurrent chemoradiotherapy according to patients willing and the surgeons' assessment. If patients were accessed with unresectable disease after radiotherapy or refused to receive surgery, Cardonilizumab would be administered for 2 years or until disease progression.


Locations(3)

Anyang Cancer Hospital

Anyang, Henan, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Beijing, China

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NCT06421376


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