Primary Excision Combined With Preoperative Neoadjuvant and Adjuvant Therapy for Oligometastasis of Urothelial Carcinoma

December 7, 2022 updated by: The First Affiliated Hospital with Nanjing Medical University

Trials of Primary Excision Combined With Preoperative Neoadjuvant Therapy and Adjuvant Therapy Was Used as a First-line Comprehensive Therapy for Oligometastasis of Urothelial Carcinoma（UC）.

treatment of primary focal resection plus lymph node dissection combined with chemotherapy and anti-programmed cell death 1(PD-1) for Oligometastasis of urothelial carcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is designed to demonstrate that Whether the perioperative comprehensive treatment of primary focal resection plus lymph node dissection combined with chemotherapy and anti-PD-1 can prolong the overall survival of patients, narrow the range of metastatic lesions and improve the quality of life of patients.

Compared with patients with extensive metastasis, 2-year tumor-specific survival and overall survival of patients with oligometastatic bladder cancer were significantly increased (53.3% vs 16.1%)；(51.9% vs. 15.4%).Gemcitabine plus cisplatin (GC) regimen has been shown to bring clinical benefits in neoadjuvant therapy of metastatic UC（urothelial carcinoma）.

PD-1 inhibitors have been widely used in urothelial carcinoma in recent years, and positive data have been obtained in both advanced patients and neoadjuvant patients.

If successful in this trial, it will serve to provide a therapeutic alternative for this patient who have oligometastasis of urothelial carcinoma.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Pengchao Li

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with oligometastatic urothelial carcinoma, including :patients with T2-T4 with any metastasis(T4NxM1) urothelial carcinoma diagnosed by pathology and evaluated by imaging;
  • Patients with measurable oligometastasis or with local lymph node metastasis. Measurable oligometastasis includes: A. a solitary metastatic organ, B. number of metastatic lesions of ≤3, C. the largest diameter of metastatic foci of ≤5cm, D. absence of liver metastasis. Local lymph node metastasis includes: A. for tumors of the bladder and lower ureter, the short diameter of pelvic lymph nodes was ≥8 mm B. for tumors of the renal pelvis and upper ureter, the short diameter of renal hilar lymph nodes was ≥8 mm. The researchers assessed the benefits of excision of the primary lesion.
  • Older than 18 years old.
  • Volunteer to participate in the trial, be able to provide a written informed consent, and understand and agree to comply with the study requirements and evaluation schedule.
  • Eastern Cooperative Oncology Group (ECOG) performance status <2
  • International standardized ratio or activated partial thrombin time ≤1.5 upper limit of normal value (ULN);The calculated creatinine clearance rate was ≥60ml/min;Serum total bilirubin ≤1.5×ULN;aspartate transaminase(AST), Alanine transaminase(ALT) and alkaline phosphatase ≤2.5×ULN;
  • Non-pregnant or fertile men or women must be willing to take effective contraceptive measures during the study period and ≥120 days after the last administration of tislelizumab, and the women should be negative on urine or serum pregnancy test results less than or equal to 7 days before enrollment.

Exclusion Criteria:

  • Previous therapy targeted at PD-1, PD-L1, PD-L2, Cytotoxic T-Lymphocyte Associated Protein 4(CTLA-4)or other antibodies or drugs specifically targeting T cell synergistic stimulation or checkpoint channels.
  • Other approved systemic anti-cancer therapies or systemic immune modulators (including but not limited to interferon, interleukin-2, and tumor necrosis factor) were received within 28 days prior to enrollment.
  • Severe chronic or active infections requiring systemic antimicrobial, antifungal, or antiviral therapy within 14 days prior to enrollment.
  • Major surgery or major trauma occurred within 28 days prior to enrollment.
  • Live vaccine was administered within 28 days before enrollment.
  • Received any herbal or proprietary Chinese medicine used to control cancer in the 14 days prior to enrollment.
  • Active autoimmune disease requiring long-term use of large amounts of hormones and other immunosuppressive agents.
  • The researchers identified abnormalities in potassium, sodium, calcium, or hypoalbuminemia, interstitial lung disease, non-infectious pneumonia, or other uncontrolled whole-body diseases, including diabetes, hypertension, and cardiovascular disease, that may affect treatment.
  • A history of HIV, hepatitis B virus(HBV)and hepatitis C virus(HCV) infection is known.
  • A history of known allergic reactions to any of the drugs studied.
  • Is participating in additional clinical studies.
  • The researcher believes that the patient is not suitable to participate in this study (such as the treatment that does not meet the patient's greatest benefit, patient compliance, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subgroup1:Patients who can tolerate cisplatin chemotherapy

GC plus Tislelizumab Participants receive GC (Gemcitabine plus cisplatin), in combination with Tislelizumab administered intravenously (IV) every 3 weeks (Q3W) before surgery.Immunotherapy was continued for 6 months after excision of the primary lesion.

Intervention/treatment： Biological: Tislelizumab Tislelizumab IV infusion of 200 mg Q3W

Biological: GC GC (Gemcitabine plus cisplatin): Gemcitabine 1000mg/m2 D1,D8 iv every 3 weeks Cisplatin70mg/m2,D2,3,4 iv every 3 weeks
Procedure: primary focal resection plus lymph node dissection
Primary radical resection plus lymph node dissection was performed in patients with oligometastatic urothelial carcinoma
Drug: Tislelizumab
Tislelizumab IV infusion of 200 mg Q3W
Other Names:
  • PD-1
Drug: Gemcitabine plus cisplatin
GC (Gemcitabine plus cisplatin): Gemcitabine 1000mg/m2 D1,D8 iv every 3 weeks Cisplatin70mg/m2,D2,3,4 iv every 3 weeks
Other Names:
  • GC
Experimental: Subgroup2:Patients who cannot tolerate cisplatin chemotherapy

Tislelizumab Participants receive Tislelizumab administered intravenously (IV) every 3 weeks (Q3W) before surgery.Immunotherapy was continued for 6 months after excision of the primary lesion.

Intervention/treatment： Biological: Tislelizumab Tislelizumab IV infusion of 200 mg Q3W
Procedure: primary focal resection plus lymph node dissection
Primary radical resection plus lymph node dissection was performed in patients with oligometastatic urothelial carcinoma
Drug: Tislelizumab
Tislelizumab IV infusion of 200 mg Q3W
Other Names:
  • PD-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 year overall survival(OS) rate
Time Frame: 1 year
the percentage of patients who die of any cause within first year of treatment
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival(PFS)
Time Frame: through study completion, an average of 1 year
time between the first objective recording of PD(progressive disease) or death from any cause (whichever occurs first) from random group solstice
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Qiang Lv, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

September 24, 2020

First Posted (Actual)

September 30, 2020

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-SR-264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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