Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC

Last updated: July 22, 2024
Sponsor: Peking University First Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Urothelial Carcinoma

Treatment

Radiotherapy

Chemotherapy and immunotherapy

Chemotherapy

Clinical Study ID

NCT06120374
LUXUS2.0
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed pathologic diagnosis as upper urinary tract urothelial carcinoma(UTUC);

  • High-risk UTUC: >= pT2, pN+, tumor G3 grade, multifocality or positive surgicalmargins (according to AJCC 8th edition);

  • Aged >= 18 years old;

Exclusion

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 usingreliable contraception;

  • History of malignant tumors (except skin cancer that is not malignant melanoma andin 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 otherfactors.

Study Design

Total Participants: 178
Treatment Group(s): 5
Primary Treatment: Radiotherapy
Phase:
Study Start date:
July 28, 2024
Estimated Completion Date:
June 08, 2029

Study 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.

Connect with a study center

  • Departmeng of Urology, Peking University First Hospital

    Beijing,
    China

    Active - Recruiting

  • Department of Medical Oncology, Peking University First Hospital

    Beijing,
    China

    Active - Recruiting

  • Department of Radiotherapy Oncology, Peking University First Hospital

    Beijing,
    China

    Active - Recruiting

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