A Phase 2 interventional study of Disitamab Vedotin and Toripalimab and Toripalimab and Nab-Paclitaxel in Bladder (Urothelial, Transitional Cell) Cancer, Antibody-drug Conjugates and Immunotherapy, sponsored by Tianjin Medical University Second Hospital. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Tianjin Medical University Second Hospital · Phase 2, Interventional, and Treatment
This randomized controlled trial aims to evaluate the efficacy and safety of antibody-drug conjugate (ADC) plus immunotherapy compared with immunotherapy plus chemotherapy in patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC).
Patients will be randomly assigned to receive either ADC plus immunotherapy or immunotherapy plus chemotherapy. The study will assess the effectiveness of these two treatment strategies in achieving complete response, maintaining disease control, and preserving the bladder, as well as their safety and tolerability.
The findings may help identify an effective bladder-preserving treatment strategy for patients with extensive very-high-risk NMIBC who cannot undergo complete transurethral resection.
Patients with very-high-risk non-muscle-invasive bladder cancer (VHR NMIBC) and extensive tumors that cannot be completely resected transurethrally represent a challenging population with limited bladder-preserving treatment options. Although radical cystectomy is generally recommended for these patients, some are medically unfit for or unwilling to undergo radical surgery. Systemic combination therapies may offer an alternative approach to achieving disease control and preserving the bladder.
Previous studies have demonstrated promising antitumor activity with immunotherapy combined with chemotherapy in this population. Antibody-drug conjugates (ADCs), which enable targeted delivery of cytotoxic agents, have also shown encouraging efficacy in urothelial carcinoma. However, whether ADC plus immunotherapy provides improved antitumor activity compared with immunotherapy plus chemotherapy remains uncertain.
TRUCE-06 is a prospective, multicenter, randomized, open-label, phase II screening trial comparing ADC plus immunotherapy with immunotherapy plus chemotherapy in patients with HER2-expressing, extensive transurethrally unresectable VHR NMIBC. Eligible patients will be randomly assigned in a 1:1 ratio to the two treatment groups.
The primary objective is to compare the complete response rate of high-risk disease between the two treatment strategies. Complete response of high-risk disease is defined as the absence of high-grade Ta, T1, or CIS, without progression to muscle-invasive disease, lymph node or distant metastasis, or death. Treatment response will be evaluated through transurethral resection of bladder tumor (TURBT), imaging, and urine cytology.
In addition to the primary efficacy assessment, the study will evaluate overall complete response, duration of response, progression-free survival, overall survival, safety, patient-reported outcomes, and exploratory biomarkers. The findings may inform the development of future bladder-preserving treatment strategies for patients with extensive VHR NMIBC.
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This study's planned enrollment of 150 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
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Extensive bladder tumors that cannot be completely resected transurethrally, defined by at least one of the following criteria:
Exclusion Criteria:
Participants will receive disitamab vedotin (RC48) plus toripalimab every 3 weeks for four initial treatment cycles. Following response assessment, treatment will continue with disitamab vedotin for up to six additional cycles and toripalimab for up to 20 cycles, according to the study protocol.
Drug: Disitamab Vedotin and Toripalimab
Participants will receive toripalimab plus nanoparticle albumin-bound paclitaxel (nab-paclitaxel) every 3 weeks for four initial treatment cycles. Following response assessment, combination treatment may continue for up to 14 cycles, according to the study protocol.
Drug: Toripalimab and Nab-Paclitaxel
Drug pages: Disitamab vedotin · Toripalimab
Disitamab vedotin is a HER2-targeted antibody-drug conjugate. Toripalimab is a monoclonal antibody targeting programmed cell death protein 1 (PD-1). They are administered intravenously every 3 weeks.
Drug pages: Toripalimab · Albumin-Bound Paclitaxel
Toripalimab is a monoclonal antibody targeting programmed cell death protein 1 (PD-1). Nab-paclitaxel is an albumin-bound formulation of paclitaxel. They are administered intravenously every 3 weeks.
Complete Response Rate of High-Risk Disease
The proportion of patients achieving complete response of high-risk disease, defined as the absence of high-grade Ta, T1, or carcinoma in situ (CIS), without progression to muscle-invasive bladder cancer, lymph node or distant metastasis, or death. Treatment response will be assessed using transurethral resection of bladder tumor (TURBT), imaging, and urine cytology.
Time frame: At the initial response assessment after 4 treatment cycles (approximately 12 weeks)
Progression-Free Survival (PFS)
Time from randomization to disease progression or death from any cause.
Time frame: From randomization, assessed up to 2 years
Duration of Response (DOR)
Time from the first documented complete response to disease recurrence, progression, or death, as defined in the protocol.
Time frame: From first documented CR, assessed up to 2 years
Overall Complete Response Rate
Proportion of patients achieving complete disappearance of all bladder tumors, including both high-grade and low-grade disease.
Time frame: At initial response assessment, approximately 12 weeks
Overall Survival (OS)
Time from randomization to death from any cause
Time frame: From randomization, assessed up to 2 years
Patient-reported health-related quality of life measured by EQ-5D-5L
Health-related quality of life (HRQoL) will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The questionnaire evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-level scale ranging from 1 (no problems) to 5 (extreme problems or inability to perform the activity), with higher levels indicating worse health status. The EQ Visual Analogue Scale (EQ VAS) ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating better self-reported health status.
Time frame: Up to 24 months from randomization.
Patient-reported health-related quality of life measured by EORTC QLQ-C30
Health-related quality of life (HRQoL) will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), version 3.0. The questionnaire comprises 30 items assessing global health status/quality of life, five functional scales, three symptom scales, and six single-item measures. According to the official EORTC scoring manual, all scale and single-item scores are linearly transformed to a range of 0 to 100. Higher scores on the global health status/quality of life scale and functional scales indicate better health-related quality of life and functioning, whereas higher scores on symptom scales and single-item measures indicate greater symptom burden or problems and therefore worse outcomes.
Time frame: Up to 24 months from randomization.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Mar 2028, 16 months later.
Of 392 non-industry phase 2 interventional studies under Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 90. This study's planned 16 months is below that.
Counting every sponsor, half of 554 studies reached it within 52 months; a quarter within 33 and three quarters within 88.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Disitamab vedotin · Toripalimab
Tianjin Medical University Second Hospital