Effectiveness of S-1-Based Chemoradiotherapy in Patients 70 Years and Older With Esophageal Squamous Cell Carcinoma: A Randomized Clinical Trial.
Xin Wang, Weiming Han, Wencheng Zhang...
https://pubmed.ncbi.nlm.nih.gov/37195667Actively Recruiting
Phase 2
Age: 18Years - 80Years
All Genders
ID06912074
Comparing Hypofractionated Concurrent Chemoradiotherapy Versus Conventional Fractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Led by Sun Yat-sen University · Updated on 2025-11-17
134
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two types of chemoradiotherapy to treat patients with unresectable locally advanced esophageal squamous cell carcinoma. This prospective, open-label, randomized phase II clinical trial compares the effectiveness and side effects of hypofractionated concurrent chemoradiotherapy versus conventional fractionated concurrent chemoradiotherapy after patients receive induction chemoimmunotherapy. The study aims to improve treatment outcomes for this challenging condition. All participants first receive two cycles of induction therapy combining albumin-bound paclitaxel, cisplatin, and toripalimab. Then, they are randomly assigned to one of two groups: one group receives hypofractionated radiotherapy once daily, five days a week, followed by a radiotherapy boost if certain conditions are met; the other group receives conventional fractionated radiotherapy with a total dose delivered in smaller daily fractions. Concurrent chemotherapy with oral capecitabine is also given during radiotherapy. During the study, patients will have tumor response and cardiopulmonary function assessments, including endoscopy and imaging, to guide treatment. Follow-up visits will monitor progression-free survival, overall survival, response rates, and treatment-related toxicities for up to two years. Safety and efficacy are carefully evaluated through clinical exams, laboratory tests, and imaging. Participation may last several years with regular visits for monitoring and outcome measurement.
CONDITIONS
Brief Title
Hypofractionated vs. Conventional Chemoradiotherapy After Induction Chemo-immunotherapy for Unresectable Esophageal Squamous Cell Carcinoma
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Pathologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma
- Evaluated as unresectable locally advanced esophageal squamous cell carcinoma with staging II-IVB (stage IVB limited to celiac or supraclavicular lymph node metastasis)
- Male or female aged 18 to 80 years
- Eligible for oral drug therapy
- No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy
- Must provide adequate unstained, archived tumor tissue samples
- Expected survival of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Postmenopausal women or women with a negative pregnancy test within 14 days before study drug administration
- Women must not be breastfeeding
- Organ and bone marrow function meeting specified criteria including FEV1 ≥1000 mL, neutrophils ≥1.5 x10^9/L, platelets ≥100 x10^9/L, hemoglobin ≥90 g/L, eGFR ≥50 mL/min, bilirubin ≤1.5 times ULN, ALT and AST ≤2.5 times ULN
- Signed informed consent before participation
You will not qualify if you...
- Participation in another clinical trial unless observational
- Use of immunosuppressive drugs within 28 days before first Toripalimab infusion, excluding low-dose corticosteroids
- Prior use of anti-PD-1 or anti-PD-L1 antibodies
- Major surgery within 4 weeks before study entry (excluding vascular access)
- Autoimmune disease history within past 2 years
- Active or history of inflammatory bowel disease such as Crohn's or ulcerative colitis
- Primary immunodeficiency history
- History of organ transplantation requiring immunosuppression
- Uncontrolled infections or serious heart, liver, or bleeding disorders
- Recent live attenuated vaccine within 30 days before or after Toripalimab
- Another primary cancer within 5 years except certain skin or cervical cancers
- Pregnancy, breastfeeding, or not using effective contraception
- Development of distant metastasis excluding celiac or supraclavicular lymph nodes after induction
- Local regional progression preventing definitive chemoradiotherapy
- Performance status score of 2 to 4
- Organ and bone marrow dysfunction including FEV1 <1000 mL, neutrophils <1.5 x10^9/L, platelets <100 x10^9/L, hemoglobin <90 g/L, creatinine clearance <50 mL/min, bilirubin >1.5 times ULN, ALT or AST >2.5 times ULN
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)
Induction Chemoimmunotherapy
Duration - Approximately 6 weeks
Participants receive two cycles of induction therapy with albumin-bound paclitaxel and cisplatin combined with toripalimab.
Multiple visits during two treatment cycles
Treatment
Duration - Approximately 5 to 9 weeks depending on treatment group
Participants are randomly assigned to receive either hypofractionated concurrent chemoradiotherapy or conventional fractionated concurrent chemoradiotherapy, both combined with concurrent chemotherapy (oral capecitabine).
Daily visits, five days per week during radiotherapy; additional visits for chemotherapy administration
Follow-up
Duration - Up to 2 years
Participants undergo regular follow-up visits to assess treatment efficacy and safety after completion of chemoradiotherapy.
Regular follow-up visits (frequency not specified)
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
B
Bo Qiu
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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SuPing Guo, FangJie Liu, Hui Liu...
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Y-P Song, J-B Ma, L-K Hu...
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B D Minsky, D Neuberg, D P Kelsen...
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Yujia Zhu, Jing Wen, Qiaoqiao Li...
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L E Gaspar, K Winter, W I Kocha...
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Yun Chen, Jinjun Ye, Zhengfei Zhu...
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Bruce D Minsky, Thomas F Pajak, Robert J Ginsberg...
https://pubmed.ncbi.nlm.nih.gov/11870157