Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC
NCT ID: NCT06120374
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
178 participants
OBSERVATIONAL
2022-01-01
2029-06-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adjuvant radioimmunotherapy
Participants underwent adjuvant radioimmunotherapy
Radiotherapy
For participants eligible for enrollment, radiotherapy was started within 4-6 weeks after surgery. Rotational intensity-modulated radiotherapy (VMAT) with daily image-guided radiotherapy (Daily IGRT) technique was used.
Range of irradiation (patients were randomized into two groups - expanded field irradiation group and involved field irradiation group)
Immunotherapy
For patients eligible for enrollment, sequential adjuvant immuotherapy was initiated at about 4-6 weeks after surgery, Immunotherapeutic agents include (PD-1/PD-L1) to be used every 21 days postoperatively for one year.
Adjuvant chemotherapy
Participants underwent radical total nephroureterectomy and adjuvant chemotherapy
Chemotherapy
For patients eligible for enrollment, postoperative adjuvant chemotherapy was initiated at about 4-6 weeks after surgery, for a total of 4 cycles, with the chemotherapy regimen of gemcitabine + cisplatin. Administration: Gemcitabine 1,000 mg/m2 on days 1 and 8 (completed within 30-60 minutes), cisplatin 70 mg/m2 on day 1.
Interventions
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Radiotherapy
For participants eligible for enrollment, radiotherapy was started within 4-6 weeks after surgery. Rotational intensity-modulated radiotherapy (VMAT) with daily image-guided radiotherapy (Daily IGRT) technique was used.
Range of irradiation (patients were randomized into two groups - expanded field irradiation group and involved field irradiation group)
Chemotherapy
For patients eligible for enrollment, postoperative adjuvant chemotherapy was initiated at about 4-6 weeks after surgery, for a total of 4 cycles, with the chemotherapy regimen of gemcitabine + cisplatin. Administration: Gemcitabine 1,000 mg/m2 on days 1 and 8 (completed within 30-60 minutes), cisplatin 70 mg/m2 on day 1.
Immunotherapy
For patients eligible for enrollment, sequential adjuvant immuotherapy was initiated at about 4-6 weeks after surgery, Immunotherapeutic agents include (PD-1/PD-L1) to be used every 21 days postoperatively for one year.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* High-risk UTUC: \>= pT2, pN+, tumor G3 grade, multifocality or positive surgical margins (according to AJCC 8th edition);
* Aged \>= 18 years old;
Exclusion Criteria
* History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy;
* Pregnant or lactating women; or women of childbearing potential who are not using reliable contraception;
* History of malignant tumors (except skin cancer that is not malignant melanoma and in situ cervical cancer, tumors that have been cured for more than 5 years);
* Weight loss \> 10% within 6 months;
* Existing or coexisting bleeding disorders, active infection;
* Terrible condition cannot tolerate the intervention;
* Unable to sign informed consent due to psychological, family, social and other factors.
18 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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Xuesong Li
Department of Urology
Principal Investigators
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Xiaoying Li, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Radiotherapy Oncology, Peking University First Hospital
Liqun Zhou, M.D.
Role: STUDY_CHAIR
Department of Urology, Peking University First Hospital
Locations
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Departmeng of Urology, Peking University First Hospital
Beijing, , China
Department of Medical Oncology, Peking University First Hospital
Beijing, , China
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Xuesong Li, M.D.
Role: primary
Chunru Xu, M.D.
Role: backup
Shikai Wu, M.D.
Role: primary
Jinglin Yu, M.D.
Role: backup
Xianshu Gao, M.D.
Role: primary
Xiaoying Li, M.D.
Role: backup
References
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Seisen T, Krasnow RE, Bellmunt J, Roupret M, Leow JJ, Lipsitz SR, Vetterlein MW, Preston MA, Hanna N, Kibel AS, Sun M, Choueiri TK, Trinh QD, Chang SL. Effectiveness of Adjuvant Chemotherapy After Radical Nephroureterectomy for Locally Advanced and/or Positive Regional Lymph Node Upper Tract Urothelial Carcinoma. J Clin Oncol. 2017 Mar 10;35(8):852-860. doi: 10.1200/JCO.2016.69.4141. Epub 2017 Jan 3.
Birtle A, Johnson M, Chester J, Jones R, Dolling D, Bryan RT, Harris C, Winterbottom A, Blacker A, Catto JWF, Chakraborti P, Donovan JL, Elliott PA, French A, Jagdev S, Jenkins B, Keeley FX Jr, Kockelbergh R, Powles T, Wagstaff J, Wilson C, Todd R, Lewis R, Hall E. Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial. Lancet. 2020 Apr 18;395(10232):1268-1277. doi: 10.1016/S0140-6736(20)30415-3. Epub 2020 Mar 5.
Li X, Li H, Gao XS, Fang D, Qin S, Zhang Z, Zhou L, Li X, Wang D. Effectiveness of adjuvant radiotherapy for high recurrence risk patients with upper tract urothelial carcinoma. Urol Oncol. 2022 Sep;40(9):410.e1-410.e10. doi: 10.1016/j.urolonc.2022.03.006. Epub 2022 Apr 14.
Li X, Cui M, Gu X, Fang D, Li H, Qin S, Yang K, Zhu T, Li X, Zhou L, Gao XS, Wang D. Pattern and risk factors of local recurrence after nephroureterectomy for upper tract urothelial carcinoma. World J Surg Oncol. 2020 May 30;18(1):114. doi: 10.1186/s12957-020-01877-w.
Other Identifiers
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LUXUS2.0
Identifier Type: -
Identifier Source: org_study_id