Actively Recruiting
Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC
Led by Sun Yat-sen University · Updated on 2026-04-21
242
Participants Needed
1
Research Sites
246 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
Definitive chemoradiotherapy (CRT) is the standard treatment for locally advanced unresectable esophageal cancer, but its efficacy remains unsatisfactory. More importantly, there is a lack of effective consolidation treatment after CRT, resulting in a high recurrence rate. Our previous prospective phase II trial (EC-CRT-001) demonstrated that the addition of toripalimab to definitive CRT improved the complete response rate in patients with locally advanced esophageal squamous cell carcinoma (ESCC), showing potential for enhanced long-term survival with a manageable safety profile. Nevertheless, the risk of recurrence requires further reduction. Metronomic capecitabine chemotherapy can modulate the tumor immune microenvironment and may synergize with PD-1 antibodies to enhance antitumor efficacy, potentially further prolonging survival in ESCC. Based on current research advances and our preliminary findings, this randomized, controlled, multicenter, phase III clinical trial aims to evaluate the efficacy and safety of toripalimab combined with capecitabine as maintenance therapy for patients with locally advanced ESCC who have not progressed after definitive CRT.
CONDITIONS
Official Title
Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed squamous cell carcinoma of the esophagus
- Locally advanced esophageal cancer stage I-IVA (inoperable or patient declined surgery) or stage IVB with supraclavicular lymph node metastasis only
- Completed definitive concurrent chemoradiotherapy without disease progression
- Radiotherapy dose of 50-50.4 Gy with conventional fractionation and IMRT technique
- Concurrent platinum- or taxane-based doublet chemotherapy during radiotherapy
- Up to 4 cycles of induction chemotherapy allowed before radiotherapy
- PD-1/PD-L1 antibody therapy allowed during induction chemotherapy and radiotherapy
- No adjuvant therapy received after chemoradiotherapy
- Enrollment within 1 to 42 days after chemoradiotherapy completion
- Age between 18 and 75 years
- Estimated life expectancy over 6 months
- Eastern Cooperative Oncology Group performance status 0 to 2
- Adequate organ function including specified blood counts, liver and kidney function
- Ability to understand the trial and provide written informed consent
You will not qualify if you...
- Received any antitumor therapy after chemoradiotherapy (adjuvant chemotherapy, surgery, immunotherapy, targeted therapy)
- Stage IVb with solid organ metastasis at 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 specified exceptions
- Severe cardiac, pulmonary, hepatic, renal dysfunction, blood diseases, cachexia, or other conditions making chemotherapy unsuitable
- Pregnant or breastfeeding women
- Unable to provide informed consent due to psychological, social, or other reasons
- Peripheral neuropathy grade 2 or higher
- Diabetes for more than 10 years with poor blood sugar control
- History of autoimmune disease or disorders, immunodeficiency, organ or bone marrow transplantation
- History of interstitial lung disease or non-infectious pneumonia
- Active hepatitis B or hepatitis C infection
- Any unstable condition risking safety or compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
M
Mian Xi, MD
CONTACT
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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