The safety and efficacy of intraluminal cryoablation combined with adjuvant immunotherapy in upper urinary tract urothelial carcinoma: an explorative study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000029669

Enrollment

Unknown

Registered

2020-02-09

Start date

2020-02-15

Completion date

Unknown

Last updated

2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper urinary tract urothelial carcinoma

Interventions

Study group:Ureteroscopic/percutaneous nephroscopic cryoablation with or without laser excision, along with postoperative adjuvant immunotherapy or combination

Control group:Radical nephroureterectomy with bladder cuff excision, along with postoperative adjuvant immunotherapy or combination of adjuvant immunotherapy and systemic GC chemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, aged 18 to 85 years; 2. Upper urinary tract urothelial carcinoma with either clinical and radiological evidence or pathological evidence; 3. The number of tumor sites on either side of the body is no more than 2; 4. The diameter of a single tumor is no longer than 3cm; 5. Patients that understand the nature of the procedure and provides written informed consent; 6. Patients that are willing to comply with follow-up, treatment and examination during the study.

Exclusion criteria

Exclusion criteria: 1. Patients accompanied by uncontrollable active infections; 2. Patients who have severe coagulopathy; 3. Patients suffering from severe heart, brain, lung, liver, kidney diseases, that cannot tolerate the surgery; 4. Patients suffering from other malignant tumors; 5. Patients with distant metastasis or pelvic lymph nodes enlargement(N1/N2/M1); 6. Pregnant or lactating women; 7. Patients with contraindication of either systemic chemotherapy or radiotherapy 8. Patients enrolled in any other trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints; 9. Patients who have any other conditions that are not appropriate for the clinical trial.

Design outcomes

Primary

Measure	Time frame
Overall survival;	—

Secondary

Measure	Time frame
Disease-free survival;Progression-free survival;	—

Countries

China

Contacts

Public ContactJiang Haowen

Department of Urology, Huashan Hospital Affiliated to Fudan University

oncouro_jhw@126.com+86 13003255733

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026