Upper Tract Urothelial Carcinoma (UTUC) Clinical Trials

Find Upper Tract Urothelial Carcinoma (UTUC) Clinical Trials Near You

Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced Upper Tract Urothelial Carcinoma: a Prospective Observational Cohort Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product, Other
Study Type: Observational
SUMMARY

This is a prospective cohort study to analyse the safety and efficacy of postoperative adjuvant radiotherapy combined with immunotherapy versus surgery alone group of UTUC patients with T3-4 stages or lymph nodes metastasis(N+) status.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 1\) Patients after radical nephroureterectomy with full-length nephroureterectomy and pathologically confirmed cancer of the renal pelvis or ureter, AJCC staging (8th edition) containing one of the following factors: pT3-4, pN+; 2) Patients with creatinine eGFR \<60 min/L. or underlying disease refusing to tolerate chemotherapy.

• 18≤age≤80 years old; 4)Completion of abdominopelvic CT 4 weeks prior to enrolment. 5)Except for cutaneous non-melanoma and ductal carcinoma in situ of the breast, the patient has not suffered from any other malignant disease within the last 5 years; 6)Willing to participate in perfecting the necessary examinations and follow-up visits for the sake of the study, and willing to provide written informed consent.

⁃ All of the above need to be fulfilled:

⁃ Expected survival \> 6 months; KPS \> 70 points; Leukocytes ≥ 3.5 x 109/l,Neutrophils ≥ 1.5 x 109/l, Platelets ≥ 100.0 x 109/l, Haemoglobin ≥ 90g/l.

Locations
Other Locations
China
Departmeng of Urology, Peking University First Hospital
RECRUITING
Beijing
Department of Radiotherapy Oncology, Peking University First Hospital
RECRUITING
Beijing
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2027-08-30
Participants
Target number of participants: 60
Treatments
Observation cohort
Patients in the observation group were T3-4 or N+ UTUC patients who were intolerant to chemotherapy or refused chemotherapy after radical surgery. No postoperative treatment was performed, and the patients were regularly rechecked.
Postoperative immunotherapy+radiotherapy
Adjuvant Immunotherapy: Immunotherapy drug of choice is tirilizumab, which has received national recommendations in metastatic uroepithelial cancer. Tirelizumab 200mg Q3w; the duration of immunotherapy is recommended for at least 1 year.~Adjuvant radiotherapy can be given concurrently or sequentially with adjuvant immunotherapy; it is recommended that radiotherapy can be started within 4-6 weeks after surgery. Rotational intensity-modulated radiotherapy (VMAT), daily image-guided radiotherapy (Daily IGRT) techniques are used.
Sponsors
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov