Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT06912074

Hypofractionated vs. Conventional Chemoradiotherapy After Induction Chemo-immunotherapy for Unresectable Esophageal Squamous Cell Carcinoma

Led by Sun Yat-sen University · Updated on 2025-11-17

134

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective, open-label, randomized phase II clinical trial designed to compare the efficacy and toxicity of hypofractionated concurrent chemoradiotherapy versus conventional fractionated concurrent chemoradiotherapy following induction chemoimmunotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma.

CONDITIONS

Official 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

Eligible

You may qualify if you...

  • Pathologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma
  • Evaluated as unresectable locally advanced esophageal squamous cell carcinoma by imaging and endoscopic studies, with staging II-IVB (IVB limited to celiac or supraclavicular lymph nodes)
  • 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 for analysis
  • 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 within specified limits: FEV1 ≥1000 mL; absolute neutrophil count ≥1.5 × 10^9/L; platelets ≥100 × 10^9/L; hemoglobin ≥90 g/L; estimated glomerular filtration rate ≥50 mL/min; serum bilirubin ≤1.5 × upper limit of normal; ALT and AST ≤2.5 × upper limit of normal
  • Signed and dated informed consent provided before participation
Not Eligible

You will not qualify if you...

  • Participation in another clinical trial unless observational
  • Use of immunosuppressive drugs within 28 days before first toripalimab infusion except certain low-dose corticosteroids
  • Prior use of any anti-PD-1 or anti-PD-L1 antibody
  • Major surgery within 4 weeks before study entry (excluding vascular access procedures)
  • History of autoimmune disease within past 2 years
  • Active or history of inflammatory bowel disease
  • History of primary immunodeficiency
  • History of organ transplantation requiring immunosuppression
  • Uncontrolled complications including infections, symptomatic heart failure, poorly controlled hypertension, unstable angina, arrhythmias, active peptic ulcer or gastritis, bleeding disorders, hepatitis, HIV, or psychiatric/social conditions preventing study compliance
  • Receipt of live attenuated vaccine within 30 days prior to or after toripalimab
  • History of another primary malignancy within 5 years except treated skin basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ
  • Pregnancy, breastfeeding, or ineffective contraception in reproductive potential
  • Development of distant metastasis excluding celiac or supraclavicular lymph nodes after induction treatment
  • Local progression preventing definitive chemoradiotherapy
  • ECOG performance status score of 2-4
  • Organ and bone marrow dysfunction after induction treatment below specified thresholds including FEV1 <1000 mL, neutrophils <1.5 × 10^9/L, platelets <100 × 10^9/L, hemoglobin <90 g/L, creatinine clearance <50 mL/min, serum bilirubin >1.5 × upper limit of normal, ALT and AST >2.5 × upper limit of normal

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

Loading map...

Research Team

B

Bo Qiu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here