Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced UTUC

Peking University First Hospital60 enrolled

Overview

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.

This study is a prospective cohort study. 1. Observation group: patients in the observation group were T3-4,N+ pyeloureteral cancer patients who did not tolerate chemotherapy or refused chemotherapy after radical surgery. No treatment will be given after surgery, and regular review will be conducted. 2. Postoperative immunotherapy+radiotherapy group: Adjuvant immunotherapy: the immunotherapy drug choice is tirilizumab, which has been recommended in metastatic uroepithelial cancer in China. Tirelizumab 200mg Q3w; the duration of immunotherapy is recommended to be used 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) technique is used. Irradiation range: Renal pelvis and upper ureter: ipsilateral renal fossa, para-abdominal aorta (including upper ureteral alignment area), common iliac lymph node area; Middle and lower ureteral carcinoma: parabasal abdominal aorta (renal hilar vessels and following levels), common iliac lymph node area (right side needs to include paraventricular lymph node area) + internal and external iliac lymph node area + middle and lower ureteral alignment area, entrance of the ureteral bladder. Radiotherapy dose: 45-50Gy/25f/5w, 62.5Gy/25f/5w regimen was given to suspected metastatic lymph nodes visible on imaging. Ensure that normal tissue is within the dose limits. Note: The right tumour para-abdominal aortic lymph node drainage area needs to include: para vena cava + intervening vena cava + left para-abdominal aorta Left tumour para-abdominal lymph node drainage area needs to include: intervening vena cava + left para-abdominal aorta

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ureter Cancer Renal Pelvic Carcinoma Advanced Urothelial Carcinoma

Interventions

Immunotherapy+radiotherapyCOMBINATION_PRODUCT

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.

surveillance aloneOTHER

Patients recieve surveillance alone without any adjuvant interventions until any disease progression endpoints occur.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. 3)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. Exclusion Criteria: * 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.

Locations (2)

Departmeng of Urology, Peking University First Hospital

Beijing, China

RECRUITING

Department of Radiotherapy Oncology, Peking University First Hospital

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

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-year

Secondary Outcomes

overall survival，the time from randomization to the date of death from any cause

Time frame: 1-year and 3-year

CSS

Cancer-specific survival，the time from randomization to the date of death due to disease (urothelial cancer).

Time frame: 1-year and 3-year

Data from ClinicalTrials.gov

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