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Recruiting NCT06421376

Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer

Phase II Interventional Esophageal Cancer Immunotherapy Induction Therapy Chemoradiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cardonilizumab, Chemoradiotherapy ±immunotherapy, Radical surgery.
Who it may be relevant to
Registry conditions: Esophageal Cancer, Immunotherapy, Induction Therapy, Chemoradiotherapy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Cardonilizumab
    Two cycles of Inductive therapy： nab-paclitaxel 250mg/ m2+cisplatin 75mg/ m2+Cardonilizumab 10mg/kg，ivgtt，3 weeks per cycle for 2 cycles
  • Radiation Chemoradiotherapy ±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
  • Procedure Radical 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.

Primary outcome measures

  • Event-free survival [Time frame: 1-year]
Secondary outcome measures (4)
  • Overall survival [Time frame: 1-year]
  • Adverse events [Time frame: 1-year]
  • Locoregional recurrence free survival [Time frame: 1-year]
  • Distant metastasis free survival [Time frame: 1-year]

Eligibility criteria

Inclusion criteria

  • 18-80 years old；
  • Eligible patients were histologically confirmed esophageal squamous cell carcinoma;
  • Eligible patients were proven locally advanced ESCC (cT1-2N1-3M0-1, cT3/T4N0-3M0-1, M1 was limited to supraclavicular lymph node metastasis）diagnosed by computed tomography \[CT\] and/or endoscopic ultrasonography \[EUS\] according to the American Joint Committee on Cancer (AJCC) 8th edition staging system；
  • ECOG PS score: 0\~1；
  • Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL;

Exclusion criteria

  • Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
  • patients who had previously received other treatments
  • At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites
  • Those who already have esophageal perforation or are at high risk of esophageal perforation
  • Patients whose tumors invade close to large blood vessels and are at risk of bleeding in the
  • there are active infections, such as active tuberculosis and hepatitis
  • There are contraindications to immunotherapy.
  • Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures
  • Combined with serious cardiovascular diseases, such as uncontrolled heart failure, coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or a history of myocardial infarction within the past 6 months; and those combined with other uncontrolled acute and chronic diseases such as hypertension and diabetes.
  • Violation of inclusion and exclusion criteria, or other reasons that the researcher believes cannot continue the study of drug treatment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • Anyang Cancer Hospital — Anyang
  • The First Affiliated Hospital of Xinxiang Medical University — Xinxiang
  • Department of Radiation Oncology, National Cancer Center/National Clinical Research Center — Beijing

Identifiers

NCT: NCT06421376 · NCC4475

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗