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RecruitingNCT06120374Updated Dec 30, 2025

Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC

An observational study in Urothelial Carcinoma, sponsored by Peking University First Hospital. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by Peking University First Hospital · Observational

From the registry’s dates

  • Started Jan 2022; still recruiting 4 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
178
Ages
18 Years and older
Sex
All
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Study summary

This study is an ambispective cohort observational study to analyze the efficacy of adjuvant radioimmunotherapy (radiotherapy and immunotherapy) compared with adjuvant chemotherapy in patients with the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pT2 and above, N+, G3/high-grade and multiple tumors, positive cut margins). A subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. Patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.

Read the detailed description

This study is an ambispective cohort observational study to analyze the efficacy of adjuvant radioimmunotherapy (radiotherapy and immunotherapy) compared with adjuvant chemotherapy in patients with the upper urinary tract urothelial carcinoma with high-risk factors (postoperative pathology suggestive of pT2 and above, N+, G3/high-grade and multiple tumors, positive cut margins). A subgroup analysis was performed to obtain the population of patients who might benefit from different treatment approaches. Patients with high risk factors for postoperative recurrence or metastasis will be treated with relevant adjuvant therapy, which in turn will benefit patients.

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Conditions studied

  • Urothelial Carcinoma

Keywords

  • upper tract urothelial carcinoma
  • adjuvant therapy
  • adjuvant radiotherapy
  • adjuvant chemotherapy
  • immunotherapy
  • safety analysis
  • progression free survival
  • overall survival
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In context

Carcinoma, Transitional Cell

716 studies on the registry are indexed under Carcinoma, Transitional Cell; 201 are open to participants now.

This study's planned enrollment of 178 is below the median of 200 across 123 observational studies indexed under Carcinoma, Transitional Cell.

Browse Carcinoma, Transitional Cell studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

High-risk UTUC patients (met at least one of indications such as: 1. pT2+, 2.G3/High-grade, 3.Multifocality, 4. Positive surgical margin, 5. Positive lymph-node metastasis

Inclusion criteria

  • Confirmed pathologic diagnosis as upper urinary tract urothelial carcinoma(UTUC);
  • High-risk UTUC: >= pT2, pN+, tumor G3 grade, multifocality or positive surgical margins (according to AJCC 8th edition);
  • Aged >= 18 years old;

Exclusion criteria

Exclusion Criteria:

  • With Distant metastases already found at the time of surgery; non-R0 resected ;
  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
178 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adjuvant radioimmunotherapy

    Participants underwent adjuvant radioimmunotherapy

    Radiation: Radiotherapy · Drug: Immunotherapy

  • Adjuvant chemotherapy

    Participants underwent radical total nephroureterectomy and adjuvant chemotherapy

    Drug: Chemotherapy

Interventions

  • RadiationRadiotherapy

    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)

    Also known as: SBRT

  • DrugChemotherapy

    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.

    Also known as: Based on platinum and gemcitabine

  • DrugImmunotherapy

    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.

    Also known as: Mainly on PD-1/PD-L1

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What researchers measure

Primary outcomes

  1. PFS

    Progression-free Survival

    Time frame: 1-year, 3-year and 5-year

Secondary outcomes

  1. OS

    Overall survival

    Time frame: 1-year, 3-year and 5-year

  2. CSS

    Cancer specific survival

    Time frame: 1-year, 3-year and 5-year

  3. LRFS

    Local recurrence free survival

    Time frame: 1-year, 3-year and 5-year

  4. MFS

    Metastasis free survival

    Time frame: 1-year, 3-year and 5-year

  5. IRFS and CRFS

    intravesical-recurrence free survival and contralateral-recurrence free survival

    Time frame: 1-year, 3-year and 5-year

Other outcomes

  1. AE

    Adverse effects

    Time frame: Peri-therapeutic period

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Study locations

3 of 3 sites recruiting
  • Departmeng of Urology, Peking University First Hospital
    Beijing, China
    Recruiting
  • Department of Medical Oncology, Peking University First Hospital
    Beijing, China
    Recruiting
  • Department of Radiotherapy Oncology, Peking University First Hospital
    Beijing, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 28045620 ↗
  • 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. PubMed 32145825 ↗
  • 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. PubMed 35431134 ↗
  • 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. PubMed 32473636 ↗

Individual participant data

Plan to share: Yes — Researchers can ask the prime investigator for the IPD.

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06120374
Lead sponsor
Peking University First Hospital
Responsible party
Xuesong Li (Department of Urology, Peking University First Hospital) — Principal investigator
First posted
Nov 7, 2023
Start date
Jan 1, 2022
Primary completion
Jun 8, 2027 (estimated)
Completion
Jun 8, 2029 (estimated)
Last update
Dec 30, 2025

Study contacts

Xuesong Li, M.D.
Contact
pineneedle@sina.com
+86-15801399116
Chunru Xu, M.D.
Contact
xcrbdyy@126.com
+8617812172086
Xiaoying Li, M.D.
principal investigator · Department of Radiotherapy Oncology, Peking University First Hospital
Liqun Zhou, M.D.
study chair · Department of Urology, Peking University First Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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