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NCT05937438RecruitingPhase 1/2

Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Carcinoma

Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Study

Source: ClinicalTrials.gov · Last updated 29 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Esophageal squamous cell carcinoma is a common malignancy in China. Although neoadjuvant chemoradiotherapy followed by esophagectomy remains a standard modality for locally advanced esophageal squamous cell carcinoma, esophagectomy followed by postoperative radiotherapy is also prevalent in China. Several retrospective studies demonstrated that postoperative radiotherapy could improve the prognosis of patients. Nevertheless, there still existed approximately 11.5% and 17.2% of total patients developing local-regional relapse and hematological metastasis. The result of Checkmate 577 has shown that postoperative immunotherapy of nivolumab could improve the disease-free survival (median Disease-free Survival 29.7 mos vs. 11.0 mos). Therefore, investigators aimed to implement a pilot study to explore the safety and efficacy of combining postoperative radiotherapy and immunotherapy for patients with locally advanced esophageal squamous cell carcinoma after esophagectomy.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
70 (estimated)
First submitted
25 Jun 2023
Start date
1 Sept 2023
Primary completion date
30 Sept 2025
Lead sponsor
Anhui Provincial Hospital
NCT number
NCT05937438

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 70
  • From 1 Sept 2023 to the primary completion date, 30 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Less than 12 lymph nodes dissected during surgery.

Age

  • Younger than 18 years old or older than 75 years old.

Other

  • Without esophagectomy.
  • Non-squamous cell carcinoma.
  • Pathological staging of pI, IIa, IVb.
  • ECOG 2-3 g. no signature of inform consent.

Who the study is looking for

  • 18-75 years old.
  • After esophagectomy.
  • Confirmation of squamous cell carcinoma by pathological examination.
  • Pathological staging of pIIb-IVa.
  • Over 12 lymph nodes dissected during surgery.
  • ECOG 0-1.
  • Signature of inform consent by patients

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Anhui Provicial Hospital
Coordinator of this site? Confirm its status
HefeiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.