Trial Title:
Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for UTUC
NCT ID:
NCT06120374
Condition:
Urothelial Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Gemcitabine
Conditions: Keywords:
upper tract urothelial carcinoma
adjuvant therapy
adjuvant radiotherapy
adjuvant chemotherapy
immunotherapy
safety analysis
progression free survival
overall survival
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
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)
Arm group label:
Adjuvant radioimmunotherapy
Other name:
SBRT
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
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.
Arm group label:
Adjuvant chemotherapy
Other name:
Based on platinum and gemcitabine
Intervention type:
Drug
Intervention name:
Immunotherapy
Description:
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.
Arm group label:
Adjuvant radioimmunotherapy
Other name:
Mainly on PD-1/PD-L1
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Departmeng of Urology, Peking University First Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuesong Li, M.D.
Phone:
+86-15801399116
Email:
pineneedle@sina.com
Contact backup:
Last name:
Chunru Xu, M.D.
Phone:
+86-17812172086
Email:
xcrbdyy@126.com
Facility:
Name:
Department of Medical Oncology, Peking University First Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Shikai Wu, M.D.
Email:
Skywu4923@sina.com
Contact backup:
Last name:
Jinglin Yu, M.D.
Email:
Yu_jinglin@163.com
Facility:
Name:
Department of Radiotherapy Oncology, Peking University First Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xianshu Gao, M.D.
Email:
doctorgaoxs@126.com
Contact backup:
Last name:
Xiaoying Li, M.D.
Phone:
+86-13716109164
Email:
13716109164@139.com
Start date:
July 28, 2024
Completion date:
June 8, 2029
Lead sponsor:
Agency:
Peking University First Hospital
Agency class:
Other
Source:
Peking University First Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06120374
