Toripalimab combined with definitive chemoradiotherapy in locally advanced oesophageal squamous cell carcinoma (EC-CRT-001): a single-arm, phase 2 trial.
Yujia Zhu, Jing Wen, Qiaoqiao Li...
https://pubmed.ncbi.nlm.nih.gov/36990609Actively Recruiting
Phase 3
Age: 18Years - 75Years
All Genders
ID07177794
Toripalimab Combined With Capecitabine as Maintenance Therapy After Definitive Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: a Multicenter, Randomized Controlled, Phase III Trial (EC-CRT-008)
Led by Sun Yat-sen University · Updated on 2026-04-21
242
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
F
First Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a new approach to improve treatment outcomes for patients with locally advanced esophageal squamous cell carcinoma (ESCC) who have not progressed after definitive chemoradiotherapy (CRT). The study evaluates whether adding toripalimab combined with metronomic capecitabine as maintenance therapy can reduce the high recurrence rate following CRT. This phase III, randomized, controlled, multicenter trial builds on previous findings suggesting that toripalimab with CRT improves response rates and may enhance long-term survival with manageable side effects. Participants in the trial will be randomly assigned to one of two groups: one receiving toripalimab intravenously at 240 mg every three weeks for up to 16 cycles combined with oral capecitabine at 500 mg twice daily for up to one year, and the other undergoing regular observation and follow-up without additional treatment. The study treatment period lasts a maximum of one year, during which the combination therapy's safety and efficacy are closely monitored. Throughout the trial, participants will undergo regular assessments, including monitoring for disease progression, survival status, treatment-related adverse events, and clinical complete response approximately 14 to 16 weeks after radiotherapy completion. Progression-free survival will be evaluated up to 36 months from enrollment, with overall survival and safety also tracked for the same duration. The study aims to provide detailed information on the benefits and risks of this maintenance therapy approach for ESCC patients after CRT.
CONDITIONS
Brief Title
Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed squamous cell carcinoma of the esophagus
- Locally advanced esophageal cancer stage I-IVA (inoperable or declined surgery) or stage IVB thoracic esophageal cancer with supraclavicular lymph node metastasis only
- Completed definitive concurrent chemoradiotherapy without disease progression, including specific radiotherapy and chemotherapy regimens
- Enrollment within 1 to 42 days after completion of chemoradiotherapy
- Age between 18 and 75 years
- Estimated life expectancy greater than 6 months
- Eastern Cooperative Oncology Group performance status of 2 or less
- Adequate organ function based on blood counts and biochemical parameters
- Ability to understand trial details and provide written informed consent
You will not qualify if you...
- Received antitumor therapy after chemoradiotherapy completion
- Stage IVb patients with metastasis to solid organs at initial diagnosis
- Known or suspected allergy to study drugs or related agents
- Presence of esophageal fistula or hemorrhage before enrollment
- Disease progression after chemoradiotherapy
- Grade 2 or higher radiation pneumonitis before enrollment
- History of grade 3 or higher immune-related adverse events before enrollment
- Prior treatment with targeted drugs
- History of other malignant tumors except certain early-stage or non-melanoma cancers
- Severe cardiac, pulmonary, hepatic, or renal dysfunction or other serious conditions
- Pregnant or breastfeeding females
- Inability to provide informed consent
- Peripheral neuropathy grade 2 or higher
- History of diabetes over 10 years with poorly controlled glucose
- History of autoimmune diseases or immunodeficiency
- History of interstitial lung disease or non-infectious pneumonia
- Active hepatitis B or C infection
- Any unstable condition risking safety or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 1 year
Participants receive toripalimab combined with metronomic capecitabine or undergo conventional observation as maintenance therapy after completing chemoradiotherapy.
Toripalimab given by IV drip every 3 weeks for up to 16 cycles; capecitabine taken orally twice daily
Follow-up
Duration - Up to 36 months after enrollment
Participants are followed for up to 36 months to monitor survival, disease progression, and treatment-related adverse events.
Regular follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
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Research Team
M
Mian Xi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Atezolizumab following definitive chemoradiotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma - a multicenter phase 2 trial (EPOC1802).
Hideaki Bando, Shogo Kumagai, Daisuke Kotani...
https://pubmed.ncbi.nlm.nih.gov/39972105Capecitabine or Capecitabine Plus Oxaliplatin Versus Fluorouracil Plus Cisplatin in Definitive Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (CRTCOESC): A Multicenter, Randomized, Open-Label, Phase 3 Trial.
Ruinuo Jia, Tanyou Shan, Anping Zheng...
https://pubmed.ncbi.nlm.nih.gov/38710003