Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced UTUC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking University First Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
1) Distant metastases already found at the time of surgery; non-R0 resected patients 2) History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; (3) Pregnant or breastfeeding women; or women of childbearing potential who are not using reliable contraception; (4) History of malignant tumour (except skin cancer that is not malignant melanoma and cervical cancer in situ, tumours that have been cured for more than 5 years) 5) weight loss > 10% within 6 months 6) Presence of active infections in those with pre-existing or co-existing bleeding disorders 7) clinically significant cardiac disease (e.g., hypertension controlled by medication, unstable angina pectoris, New York Heart Association (NYHA) class ≥ II congestive heart failure, unstable symptomatic arrhythmia, or class ≥ II peripheral vascular disease); 8) Psychological, family, and social factors leading to lack of informed consent.
Trial population
All pT3-4/N+ UTUC patients who were eligible for enrolment and signed the informed consent could be included in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Immunotherapy+radiotherapy
Combination productAdjuvant 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.
surveillance alone
Other interventionPatients recieve surveillance alone without any adjuvant interventions until any disease progression endpoints occur.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Observation cohort1 intervention
Group B: Postoperative immunotherapy+radiotherapy1 intervention
Trial outcomes
Primary outcomes
1
DFS
Disease-free survival，The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.)
Time frame
1-year and 3-yearSecondary outcomes
1
OS
overall survival，the time from randomization to the date of death from any cause
Time frame
1-year and 3-year2
CSS
Cancer-specific survival，the time from randomization to the date of death due to disease (urothelial cancer).
Time frame
1-year and 3-yearSponsors and contacts
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Source ClinicalTrials.gov