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NCT Number: NCT06120374

Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Departmeng of Urology, Peking University First Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Radiotherapy

Radiation

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)

Other names: SBRT

Chemotherapy

Drug

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.

Other names: Based on platinum and gemcitabine

Immunotherapy

Drug

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 names: Mainly on PD-1/PD-L1

Primary outcomes

  1. PFS

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

    Progression-free Survival

Secondary outcomes

  1. OS

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

    Overall survival

  2. CSS

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

    Cancer specific survival

  3. LRFS

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

    Local recurrence free survival

  4. MFS

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

    Metastasis free survival

  5. IRFS and CRFS

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

    intravesical-recurrence free survival and contralateral-recurrence free survival

Other outcomes

  1. AE

    Time frame: Peri-therapeutic period

    Adverse effects

Study contacts

Contact information is provided by the study sponsor or research team.

Chunru Xu, M.D.

CONTACT

[email protected]

+8617812172086

Xuesong Li, M.D.

CONTACT

[email protected]

+86-15801399116

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Safety and Efficacy of Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for Upper Tract Urothelial Carcinoma: An Ambispective Cohort Study

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Nov 7, 2023
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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