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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2027-08-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Ureter Cancer Renal Pelvic Carcinoma Advanced Urothelial Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

surveillance alone

Intervention Type OTHER

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

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.

Immunotherapy+radiotherapy

Intervention Type COMBINATION_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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

surveillance alone

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No