Effect of BCG and Tislelizumab on Bladder Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness and safety of combining Bacillus Calmette-Guérin (BCG) with the PD-1 inhibitor tislelizumab for treating intermediate and high-risk non-muscle invasive bladder cancer (NMIBC). The study aims to address gaps in previous research by focusing on the clinical efficacy of this combination therapy in reducing postoperative recurrence. Eligible patients will be recruited from multiple medical centers, and strict screening criteria will be applied to ensure the selection of suitable candidates. The trial will involve comprehensive follow-up to assess treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntary participation in the trial with signed informed consent;
2. Patients aged ≥18 and ≤75 years, regardless of gender, with an expected survival of ≥2 years;
3. Histologically confirmed non-muscle-invasive bladder urothelial carcinoma with positive PD-L1 expression. According to the 2014 guidelines of the Chinese Urological Association (CUA), patients are assessed as having a medium to high risk of recurrence or progression. (For patients considering a second transurethral resection, they may be included in the study after completing the procedure and if pathology confirms medium to high risk non-muscle-invasive bladder urothelial carcinoma);
4. Performance status score (Eastern Cooperative Oncology Group, ECOG) of 0-2;
5. Completion of screening-related examinations (complete blood count, coagulation function, liver and kidney function, infectious disease screening, 12-lead ECG, urinary system ultrasound, pelvic MR, and tissue pathology examination), without surgical contraindications.

Exclusion Criteria:

1. Any of the following conditions:

   Immune deficiency or impairment (such as AIDS patients), current use of immunosuppressive drugs or radiation therapy that may cause systemic BCG disease reaction; allergy to BCG components; patients with fever and acute infectious diseases, including active tuberculosis or those undergoing anti-tuberculosis treatment; those with severe chronic cardiovascular or cerebrovascular diseases or chronic kidney disease;
2. Concurrent urogenital system tumors or tumors in other organs;
3. Muscle-invasive bladder urothelial carcinoma (stage T2 and above) patients;
4. Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation chemotherapy);
5. Pregnant or lactating women, women of childbearing age not using effective contraception, or those planning to conceive during the trial period (including male participant partners);
6. Known or suspected intraoperative bladder perforation;
7. Presence of gross hematuria prior to enrollment, suspected unhealed surgical wounds or damaged urinary mucosa;
8. Severe urethral stricture preventing cystoscopy, history of bladder contracture, or functional bladder volume less than 100mL;
9. Accompanying cystitis, or those who have received other bladder instillation medications and have severe bladder irritation signs expected to affect the assessment of this study;
10. Patients with various mental disorders, severe coagulation function, liver and kidney function, hematopoietic function disorders, etc., that cannot tolerate surgical treatment;
11. Participation in other drug clinical trials within 3 months before enrollment;
12. Known or suspected opioid or alcohol dependence;
13. Any condition that the researcher believes may increase the risk to the participant or interfere with the execution of the clinical trial.

Where it's running

• Department of Urology, Fujian Union Hospital, Fujian Medical University
  Fuzhou, Fujian, China Recruiting

Study contacts

• Principal investigator: Zhenlin Chen — Department of Urology, Fujian Union Hospital, Fujian Medical University
• Study coordinator: Jiabing Zheng
• Email: xhyykjk@163.com
• Phone: +8613799422519

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tislelizumab with Tofacitinib and Docetaxel for NSCLC After First-Line Immunotherapy

  This study tests whether adding tofacitinib to tislelizumab and docetaxel helps people with locally advanced or metastatic NSCLC who did not respond to first-line immunotherapy.

  Recruiting Phase 2 Anhui Provincial Hospital · Hefei, Anhui · NCT07925866

• SYS6010 plus Enlonstobart for recurrent or metastatic nasopharyngeal cancer in patients who have not had prior systemic therapy

  This trial tests whether SYS6010 with Enlonstobart works better than Tislelizumab with gemcitabine and cisplatin for people whose recurrent or metastatic nasopharyngeal cancer has not yet received systemic treatment.

  Recruiting Phase 3 CSPC Megalith Biopharmaceutical Co.,Ltd. · Guangzhou, Guangzhou · NCT07925021

• TMV vaccine alone or with toripalimab for recurrent head and neck cancer

  This study tests a personalized TMV vaccine, alone and with toripalimab, in adults whose head and neck cancer has returned and is planning salvage surgery.

  Recruiting Phase 1 Metaclipse Therapeutics Corporation · Houston, Texas · NCT07898124

• Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX

  This study tests whether adding fruquintinib to short-course radiotherapy plus tislelizumab and CAPOX before surgery helps people with locally advanced low rectal cancer achieve a better tumor response.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07888309

• Long-term outcomes after vacuum-induced tamponade for postpartum hemorrhage

  This study will look at women who had postpartum hemorrhage treated with vacuum-induced tamponade at a Zurich hospital to see how they fared over time, including future pregnancies and fertility.

  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07885072

• Inactivated UPEC-FimON for Bladder Cancer After BCG or Intravesical Therapy Failure

  This phase 1 study tests whether intravesical doses of inactivated UPEC-FimON are safe and tolerable in adults with non-muscle invasive bladder cancer that progressed after BCG or intravesical therapy.

  Recruiting at 3 sites Phase 1 Hopec Pharma · Kfar Saba, Central District and 2 other locations · NCT07881666

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.