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NCT Number: NCT05621707

Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Locally-advanced Esophageal Squamous Cell Cancer (RICE)

This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥ 18 years at the time of screening.
  • Histologically confirmed squamous cell carcinoma;
  • Locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery;
  • Eastern Cooperative Oncology Group (ECOG) performance status:0-2;
  • Able to eat a semi-liquid diet;
  • Less than 20% weight loss within 6 months;
  • Adequate hepatic function, renal function, hematologic function and coagulation function;
  • Documented informed consent.

Exclusion criteria

  • Distant metastasis;
  • Known malignancy diagnosed or require active treatment in the last 5 years, except for cancers that can be cured by surgery including cervical cancer in situ, basal or squamous cell skin cancer, breast ductal carcinoma in situ, localized prostate cancer;
  • Prior thoracic irradiation, chemotherapy, or lobectomy
  • Known diseases or conditions that are contraindicated for radiotherapy or surgery;
  • Allergy to the research medications;
  • Pregnant women or women preparing for pregnancy;
  • Diagnosis of autoimmune disease or history of chronic autoimmune disease
  • Absence of informed consent because of psychological, family, social and other factors;
  • Patients with comorbidities (chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, unstable mental disorders requiring therapy).

Treatment and study plan

chemotherapy combined with PD-1 inhibitors

Drug

Induction chemotherapy combined with PD-1 inhibitors followed with standard concurrent chemoradiotherapy

Primary outcomes

  1. Overall Survival Rate

    Time frame: 2 years after last patient enrolled

    Overall survival rate is defined as the percentage of participants who are alive up to 2 years from enrollment

Secondary outcomes

  1. progression-free Survival (PFS)

    Time frame: 2 years after last patient enrolled

    Progression-free survival is defined as the time between date of enrollment and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary tumor site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as PFS events.

  2. Treatment related complications

    Time frame: During the procedure

    complications after treatment

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Official study title

A Phase 2 Trial of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer

Acronym: RICE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2022
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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