Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC

NCT06120374 | Recruiting DMC

• 1 other identifier: LUXUS2.0
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Urothelial Carcinoma

Keywords

upper tract urothelial carcinoma; adjuvant therapy; adjuvant radiotherapy; adjuvant chemotherapy; immunotherapy; safety analysis; progression free survival; overall survival

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free Survival

  1-year, 3-year and 5-year

Secondary Outcomes (5)

• OS

  1-year, 3-year and 5-year

• CSS

  1-year, 3-year and 5-year

• LRFS

  1-year, 3-year and 5-year

• MFS

  1-year, 3-year and 5-year

• IRFS and CRFS

  1-year, 3-year and 5-year

Other Outcomes (1)

• AE

  Peri-therapeutic period

Study Arms (2)

Adjuvant radioimmunotherapy

Participants underwent adjuvant radioimmunotherapy

Radiation: Radiotherapy; Drug: Immunotherapy

Adjuvant chemotherapy

Participants underwent radical total nephroureterectomy and adjuvant chemotherapy

Drug: Chemotherapy

Interventions

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)

Also known as: SBRT

Adjuvant radioimmunotherapy

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.

Also known as: Based on platinum and gemcitabine

Adjuvant chemotherapy

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.

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

Adjuvant radioimmunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (3)

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

Related Publications (4)

• 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.

  PMID: 28045620 BACKGROUND

• 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.

  PMID: 32145825 BACKGROUND

• 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.

  PMID: 35431134 RESULT

• 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.

  PMID: 32473636 RESULT

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Radiotherapy; Drug Therapy; Gemcitabine; Immunotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Immunomodulation; Biological Therapy

Study Officials

• Xiaoying Li, M.D.

  Department of Radiotherapy Oncology, Peking University First Hospital

  PRINCIPAL INVESTIGATOR

• Liqun Zhou, M.D.

  Department of Urology, Peking University First Hospital

  STUDY CHAIR

Central Study Contacts

Xuesong Li, M.D.

CONTACT

+86-15801399116; pineneedle@sina.com

Chunru Xu, M.D.

CONTACT

+8617812172086; xcrbdyy@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Urology

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 7, 2023
• Study Start: January 1, 2022
• Primary Completion (Estimated): June 8, 2027
• Study Completion (Estimated): June 8, 2029
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Within six months after the project completion.
• Access Criteria: Not commercial.

Locations

CN (3)