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Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced UTUC

NCT06598761 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-11-05

No results posted yet for this study

Summary

This is a prospective cohort study to analyse the safety and efficacy of postoperative adjuvant radiotherapy combined with immunotherapy versus surgery alone group of UTUC patients with T3-4 stages or lymph nodes metastasis(N+) status.

Conditions

  • Ureter Cancer
  • Renal Pelvic Carcinoma
  • Advanced Urothelial Carcinoma

Interventions

COMBINATION_PRODUCT

Immunotherapy+radiotherapy

Adjuvant Immunotherapy: Immunotherapy drug of choice is tirilizumab, which has received national recommendations in metastatic uroepithelial cancer. Tirelizumab 200mg Q3w; the duration of immunotherapy is recommended for at least 1 year. Adjuvant radiotherapy can be given concurrently or sequentially with adjuvant immunotherapy; it is recommended that radiotherapy can be started within 4-6 weeks after surgery. Rotational intensity-modulated radiotherapy (VMAT), daily image-guided radiotherapy (Daily IGRT) techniques are used.

OTHER

surveillance alone

Patients recieve surveillance alone without any adjuvant interventions until any disease progression endpoints occur.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2026-12-31
Completion
2027-08-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06598761 on ClinicalTrials.gov