Menu
Recruiting NCT05357846

PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

Phase III Interventional Squamous Cell Esophageal Carcinoma Esophageal Cancer Oesophageal Cancer

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: Sintilimab, Preoperative radiotherapy, Paclitaxel, Cisplatin.
Who it may be relevant to
Registry conditions: Squamous Cell Esophageal Carcinoma, Esophageal Cancer, Oesophageal Cancer. Basic parameters: 18 years — 70 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

Phase III Multicenter Randomized Controlled Trial of PD-1 Inhibitor Combined With Preoperative Concurrent Chemoradiotherapy and Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC2101)

Overview

The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.

Interventions

  • Drug Sintilimab
    Sintilimab 200mg, IV (in the vein) on day 1 and day 22
  • Radiation Preoperative radiotherapy
    External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.
  • Drug Paclitaxel
    50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22
  • Drug Cisplatin
    25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22
  • Procedure esophagectomy
    McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 6-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.

Primary outcome measures

  • Overall survival [Time frame: At end of enrollment- up to 5 years in follow up]
Secondary outcome measures (5)
  • Progression free survival [Time frame: At end of enrollment- up to 5 years in follow up]
  • Pathologic complete response rate [Time frame: Two weeks after surgery]
  • R0 resection rate [Time frame: Two weeks after surgery]
  • Incidence of perioperative complications [Time frame: Ninety days after surgery]
  • Perioperative mortality [Time frame: Ninety after surgery]

Eligibility criteria

Inclusion criteria

  • Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.
  • Patients must not have received any prior anticancer therapy.
  • More than 6 months of expected survival.
  • Age ranges from 18 to 70 years.
  • Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
  • WHO PS score 0-1
  • Signed informed consent document on file.

Exclusion criteria

  • Patients have received any prior anticancer therapy.
  • Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.
  • Patients with concomitant hemorrhagic disease.
  • Patients who cannot tolerate surgery.
  • Pregnant or breast feeding.
  • Patients without informed consent because of psychological, family, social or any other factors.
  • Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
  • Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
  • Patients with history of diabetes over 10 years and unsatisfactory glycemic control.
  • Patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery.
  • Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation.
  • Patients with history of interstitial lung disease or noninfectious pneumonia.
  • Patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment.
  • Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT05357846 · NEOCRTEC2101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗