MIBCPhase 3NCT07693959
Neoadjuvant RC48 Plus Gemcitabine in HER2-Expressing MIBC
A Phase 3 study testing Gemcitabine, Toripalimab and Disitamab Vedotin (RC48) in people with MIBC, run by Zhiquan Hu at 22 sites in China.
Trial summary
Objectives: To evaluate the non-inferiority of disitamab vedotin plus gemcitabine versus disitamab vedotin plus toripalimab in terms of the pathological complete response (pCR) rate as neoadjuvant therapy for muscle-invasive bladder cancer (MIBC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MIBC
- What is being tested?
- Gemcitabine, Toripalimab and Disitamab Vedotin (RC48)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 22 sitesChina
- Study dates
- 1 Jul 2026to 1 Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent \& Compliance: Provision of signed informed consent and ability to comply with study procedures and follow-up requirements.
- Age: Age 18 to 75 years (inclusive).
- Planned Surgery: Planned to undergo radical cystectomy (RC) with lymph node dissection (LND).
- Clinical Stage: Clinical stage T2-T4aNxM0, as assessed by CT, MRI, or PET-CT.
- Pathology \& Biomarker: Histologically confirmed predominant urothelial carcinoma by cystoscopic biopsy or transurethral resection of bladder tumor (TURBT), with HER2 expression of 1+ to 3+ determined by immunohistochemistry (IHC).
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
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- Adequate Organ Function: Laboratory values meeting the following criteria: Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 80 g/L; Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × ULN
- Cardiac Function: New York Heart Association (NYHA) class < 3.
- Reproductive Status \& Contraception: *Female: Must be surgically sterile, postmenopausal, or agree to use highly effective contraception during the study and for 6 months after the last dose of study treatment. Must not be lactating. *Male: Must agree to use a medically acceptable method of contraception (e.g., condoms, abstinence) during the study and for 6 months after the last dose of study treatment.
Who cannot join
- Receipt of live attenuated vaccine within 4 weeks prior to enrollment or planned receipt during the study period.
- Receipt of systemic chemotherapy, or anti-PD-1, anti-PD-L1, or HER2-targeted therapy within the past 6 months.
- Known hypersensitivity to gemcitabine, disitamab vedotin, toripalimab, or any of their excipients.
- Active, known, or suspected autoimmune disease.
- Known history of primary immunodeficiency.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
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- Untreated acute or chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. (Patients receiving continuous antiviral therapy with monitored viral loads may be eligible at the investigator's discretion).
- Uncontrolled concurrent illness including, but not limited to: human immunodeficiency virus (HIV) infection, active or poorly controlled severe infection, or evidence of uncontrolled systemic disease (e.g., severe psychiatric/neurological disorders, decompensated respiratory failure).
- History of other malignancies within the past 5 years, excluding clinically cured early-stage tumors.
- Active tuberculosis.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
China22 sites, 22 recruiting
- Recruiting
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
Enshi, Hubei, 445000
Su Chen, M.D., 13477894099
Su Chen, M.D.
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Shaoxing Zhu, M.D., 18758872716, zsxing2005@126.com
Shaoxing Zhu, M.D.
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Abai Xu, M.D., 18665626790, lc96xab@163.com
Abai Xu, M.D.
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Hanjiang Xu, M.D., 18326170623
Hanjiang Xu, M.D.
- Recruiting
Huanggang Central Hospital
Huanggang, Hubei, 438000
Jiayi Tao, M.D., 13409868766, 35149051@qq.com
Jiayi Tao, M.D.
- Recruiting
Huangshi Central Hospital
Huangshi, Hubei, 435000
Dingwen Gui, M.D., 13971778131, 68661272@qq.com
Dingwen Gui, M.D.
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
JiaSheng Bian, M.D., 15954104097, sdbjs232466@sina.com
Jiasheng Bian, M.D.
- Recruiting
Jingmen Central Hospital
Jingmen, Hubei, 448000
Zeming Liao, M.D., 13886919765, lzm19731217@qq.com
Zeming Liao, M.D.
- Recruiting
Jingzhou First People's Hospital
Jingzhou, Hubei, 434000
Haitao Dai, M.D., 18163138773, 124316578@qq.com
Haitao Dai, M.D.
- Recruiting
Jingzhou Central Hospital
Jingzhou, Hubei, 434020
Yixiang Liao, M.D., 18107167675, 25261193@qq.com
Yixiang Liao, M.D.
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Kehua Jiang, M.D., 18571225053
Kehua Jiang, M.D.
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, 518117
Dongwen Wang, M.D., 13530336918, urology2007@126.com
Dongwen Wang, M.D.
- Recruiting
Taihe Hospital
Shiyan, Hubei, 442000
Congbo Chen, M.D., 13907204825
Congbo Chen, M.D.
- Recruiting
The Central Hospital of Wuhan
Wuhan, Hubei, 430014
Yonglian Guo, M.D., 15972152299, 15972152299@139.com
Yonglian Guo, M.D.
- Recruiting
Wuhan No.1 Hospital
Wuhan, Hubei, 430022
Gaofeng Zhou, M.D., 18507134410, 910790776@qq.com
Gaofeng Zhou, M.D.
- Recruiting
Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Zhiquan Hu, 13971656164, huzhiquan2000@163.com
Zhiquan Hu, M.D.
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Zhiyuan Chen, M.D., 13886000807, chenzhiyuan163@163.com
Zhiyuan Chen, M.D.
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Xingyuan Xiao, M.D., 18672923313, xiaoxingyuan@whu.edu.cn
Xingyuan Xiao, M.D.
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Diansheng Cui, M.D., 13871549210, 787434798@qq.com
Diansheng Cui, M.D.
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Wei Li, M.D., 13666028912
Wei Li, M.D.
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441021
Bin chen, M.D., 19908671399, 625848080@qq.com
Bin Chen, M.D.
- Recruiting
Yichang Central People's Hospital
Yichang, Hubei, 443003
Xiaobo Chen, M.D., 13972587419, 272899447@qq.com
Xiaobo Chen, M.D.
About this study
Official title: Neoadjuvant RC48 Plus Gemcitabine for HER2 1~3+ MIBC: A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Study (GUARD-02)
Objectives: To evaluate the non-inferiority of disitamab vedotin plus gemcitabine versus disitamab vedotin plus toripalimab in terms of the pathological complete response (pCR) rate as neoadjuvant therapy for muscle-invasive bladder cancer (MIBC).
This study is designed to evaluate two parallel neoadjuvant treatment strategies followed by definitive local therapy and adjuvant treatment. Eligible patients will be assigned to either the Experimental Arm, receiving neoadjuvant Disitamab Vedotin (RC48) combined with Gemcitabine, or the Active Comparator Arm, receiving neoadjuvant RC48 combined with Toripalimab. Both neoadjuvant regimens are administered every two weeks for 3 to 6 cycles, contingent upon imaging-based tumor response. Following the neoadjuvant phase, patients from both arms will proceed to receive standard Radical Cystectomy (RC) combined with Pelvic Lymph Node Dissection (PLND) within four weeks of their final dose, with a trimodality therapy (TMT) bladder-sparing approach strictly restricted to a selected minority of patients. In the postoperative phase, eligible patients will receive adjuvant therapy consisting of RC48 plus Toripalimab for 6 cycles, followed by Toripalimab maintenance monotherapy for a duration of ≤ 1 year (or a maximum of 1 year).Patients post-RC require abdominopelvic/chest imaging q3-6m; non-RC patients need cystoscopy q3m and abdominopelvic/chest CT q3-6m. Follow-up staff should proactively contact patients q3m to record imaging findings and inquire about hematuria, stomal lesions, cough/chest pain, CNS symptoms, and accurately document recurrence/progression, metastasis, death with dates.
- Conditions
- MIBC
- Being tested
- Gemcitabine, Toripalimab, Disitamab Vedotin (RC48), Radical Cystectomy
- Keywords
- MIBC, ADC, Toripalimab, RC48, Gemcitabine, Disitamab Vedotin, neoadjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
On Day 2 of each neoadjuvant therapy cycle, a dose of 1000 mg/m² is administered via intravenous infusion. The regimen is administered every 2 weeks (Q2W).
ToripalimabDrug
On Day 2 of each neoadjuvant therapy cycle, a dose of 3 mg/kg is administered via intravenous infusion. The regimen is administered every 2 weeks (Q2W).
Disitamab Vedotin (RC48)Drug
On Day 1 of each neoadjuvant therapy cycle, a dose of 2 mg/kg is administered via intravenous infusion over 30-60 minutes.
Radical CystectomyProcedure or surgery
Patients are scheduled to undergo radical cystectomy (RC) within 4 weeks after the last dose of neoadjuvant therapy, and the postoperative specimens will be assessed for pathological response.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm (RC48 + Gemcitabine) | Experimental | Patients in this arm receive neoadjuvant Disitamab Vedotin (RC48) at a dose of 2.0 mg/kg via intravenous (IV) infusion (60-90 minutes) on Day 1, followed by Gemcitabine 1000 mg/m² IV on Day 2. The regimen is administered every 2 weeks (Q2W). Tumor response is evaluated via imaging after 3 cycles. Patients who do not achieve a clinical complete response (cCR) will continue the treatment for an additional 3 cycles (totaling 3 to 6 cycles). Receives: Drug: Gemcitabine; Drug: Disitamab Vedotin (RC48); Procedure: Radical Cystectomy |
| Active Comparator Arm (RC48 + Toripalimab) | Active comparator | Patients in this arm receive neoadjuvant Disitamab Vedotin (RC48) at a dose of 2.0 mg/kg via IV infusion (60-90 minutes) on Day 1, followed by Toripalimab 3 mg/kg IV on Day 2. The regimen is administered every 2 weeks (Q2W). Tumor response is evaluated via imaging after 3 cycles, with treatment continuing for a total of 3 to 6 cycles based on the tumor response evaluation. Receives: Drug: Toripalimab; Drug: Disitamab Vedotin (RC48); Procedure: Radical Cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Defined as the absence of residual viable tumor cells (ypT0N0) in RC+PLND specimens. Assessed post-surgery. Method: A central pathology review committee performs centralized, blinded independent review of slides from all eligible patients. Sites ship de-identified slides and clinical forms to a central lab for uniform anonymization, QC, H\&E staining, and supplementary IHC if needed. All materials are fully de-identified, presented in random order without clinical data. Two senior uropathologists (associate professor level or above) read independently; consensus is final, otherwise a third senior pathologist adjudicates blindly. ypT and ypN are recorded.
Measured: Within 1 week after completion of radical cystectomy.
Secondary outcomes (1)
Incidence of Grade ≥3 Treatment-Related Adverse Events (TRAEs) During Neoadjuvant Therapy
Defined as the proportion of patients in the safety set experiencing at least one Grade ≥3 TRAE (CTCAE v5.0) during neoadjuvant therapy. Assessed from the first cycle to 4 weeks after the last cycle, with comprehensive tests each cycle, a scheduled visit 1 week after the last dose of each cycle, and immediate evaluation upon any alert or complaint. Method: Uniform site training, structured eCRF recording of AE terms, dates, grades, relatedness, actions, outcomes. An independent Clinical Endpoint Committee (CEC) conducts centralized, blinded review of all Grade ≥3 events for final adjudication.
Measured: The period starting from the first administration of neoadjuvant therapy and extending through 4 weeks following the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MIBCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiquan Hu
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital
- Responsible party
- Sponsor-investigator, Zhiquan Hu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693959
- Sponsor's protocol ID
- TJ-IRB202605029
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang H, Ma W, Zeng X, Liu B, Dai H, Zhou G, Wan J, Zhang Y, Hu Z, Yang C. Efficacy and Safety of Disitamab Vedotin Combined with Gemcitabine as Neoadjuvant Therapy in Muscle-invasive Bladder Cancer: An Open-label, Multicenter, Single-arm, Phase 2 Trial. Eur Urol. 2026 Aug;90(2):103-107. doi: 10.1016/j.eururo.2025.10.009. Epub 2025 Nov 4.
PubMed 41193372Sheng X, Yan X, Wang L, Shi Y, Yao X, Luo H, Shi B, Liu J, He Z, Yu G, Ying J, Han W, Hu C, Ling Y, Chi Z, Cui C, Si L, Fang J, Zhou A, Guo J. Open-label, Multicenter, Phase II Study of RC48-ADC, a HER2-Targeting Antibody-Drug Conjugate, in Patients with Locally Advanced or Metastatic Urothelial Carcinoma. Clin Cancer Res. 2021 Jan 1;27(1):43-51. doi: 10.1158/1078-0432.CCR-20-2488. Epub 2020 Oct 27.
PubMed 33109737
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant RC48 Plus Gemcitabine for HER2 1~3+ MIBC: A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Study (GUARD-02)
- ClinicalTrials.gov ID
- NCT07693959
- Acronym / sponsor ID
- TJ-IRB202605029
- Conditions
- MIBC
- Keywords
- MIBC, ADC, Toripalimab, RC48, Gemcitabine, Disitamab Vedotin, neoadjuvant therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Zhiquan HuUniversity, hospital or other
- Collaborators
- Tongji Hospital
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: To evaluate the non-inferiority of disitamab vedotin plus gemcitabine versus disitamab vedotin plus toripalimab in terms of the pathological complete response (pCR) rate as neoadjuvant therapy for muscle-invasive bladder cancer (MIBC).
This study is designed to evaluate two parallel neoadjuvant treatment strategies followed by definitive local therapy and adjuvant treatment. Eligible patients will be assigned to either the Experimental Arm, receiving neoadjuvant Disitamab Vedotin (RC48) combined with Gemcitabine, or the Active Comparator Arm, receiving neoadjuvant RC48 combined with Toripalimab. Both neoadjuvant regimens are administered every two weeks for 3 to 6 cycles, contingent upon imaging-based tumor response. Following the neoadjuvant phase, patients from both arms will proceed to receive standard Radical Cystectomy (RC) combined with Pelvic Lymph Node Dissection (PLND) within four weeks of their final dose, with a trimodality therapy (TMT) bladder-sparing approach strictly restricted to a selected minority of patients. In the postoperative phase, eligible patients will receive adjuvant therapy consisting of RC48 plus Toripalimab for 6 cycles, followed by Toripalimab maintenance monotherapy for a duration of ≤ 1 year (or a maximum of 1 year).Patients post-RC require abdominopelvic/chest imaging q3-6m; non-RC patients need cystoscopy q3m and abdominopelvic/chest CT q3-6m. Follow-up staff should proactively contact patients q3m to record imaging findings and inquire about hematuria, stomal lesions, cough/chest pain, CNS symptoms, and accurately document recurrence/progression, metastasis, death with dates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm (RC48 + Gemcitabine) | Experimental | Drug: Gemcitabine, Drug: Disitamab Vedotin (RC48), Procedure: Radical CystectomyPatients in this arm receive neoadjuvant Disitamab Vedotin (RC48) at a dose of 2.0 mg/kg via intravenous (IV) infusion (60-90 minutes) on Day 1, followed by Gemcitabine 1000 mg/m² IV on Day 2. The regimen is administered every 2 weeks (Q2W). Tumor response is evaluated via imaging after 3 cycles. Patients who do not achieve a clinical complete response (cCR) will continue the treatment for an additional 3 cycles (totaling 3 to 6 cycles). |
| Active Comparator Arm (RC48 + Toripalimab) | Active comparator | Drug: Toripalimab, Drug: Disitamab Vedotin (RC48), Procedure: Radical CystectomyPatients in this arm receive neoadjuvant Disitamab Vedotin (RC48) at a dose of 2.0 mg/kg via IV infusion (60-90 minutes) on Day 1, followed by Toripalimab 3 mg/kg IV on Day 2. The regimen is administered every 2 weeks (Q2W). Tumor response is evaluated via imaging after 3 cycles, with treatment continuing for a total of 3 to 6 cycles based on the tumor response evaluation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed Consent \& Compliance: Provision of signed informed consent and ability to comply with study procedures and follow-up requirements.
- Age: Age 18 to 75 years (inclusive).
- Planned Surgery: Planned to undergo radical cystectomy (RC) with lymph node dissection (LND).
- Clinical Stage: Clinical stage T2-T4aNxM0, as assessed by CT, MRI, or PET-CT.
- Pathology \& Biomarker: Histologically confirmed predominant urothelial carcinoma by cystoscopic biopsy or transurethral resection of bladder tumor (TURBT), with HER2 expression of 1+ to 3+ determined by immunohistochemistry (IHC).
Key exclusion criteria (10 listed)
- Receipt of live attenuated vaccine within 4 weeks prior to enrollment or planned receipt during the study period.
- Receipt of systemic chemotherapy, or anti-PD-1, anti-PD-L1, or HER2-targeted therapy within the past 6 months.
- Known hypersensitivity to gemcitabine, disitamab vedotin, toripalimab, or any of their excipients.
- Active, known, or suspected autoimmune disease.
- Known history of primary immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineOn Day 2 of each neoadjuvant therapy cycle, a dose of 1000 mg/m² is administered via intravenous infusion. The regimen is administered every 2 weeks (Q2W). | Drug | Experimental Arm (RC48 + Gemcitabine) |
| ToripalimabOn Day 2 of each neoadjuvant therapy cycle, a dose of 3 mg/kg is administered via intravenous infusion. The regimen is administered every 2 weeks (Q2W). | Drug | Active Comparator Arm (RC48 + Toripalimab) |
| Disitamab Vedotin (RC48)On Day 1 of each neoadjuvant therapy cycle, a dose of 2 mg/kg is administered via intravenous infusion over 30-60 minutes. | Drug | Active Comparator Arm (RC48 + Toripalimab), Experimental Arm (RC48 + Gemcitabine) |
| Radical CystectomyPatients are scheduled to undergo radical cystectomy (RC) within 4 weeks after the last dose of neoadjuvant therapy, and the postoperative specimens will be assessed for pathological response. | Procedure or surgery | Active Comparator Arm (RC48 + Toripalimab), Experimental Arm (RC48 + Gemcitabine) |
Primary outcome
Pathological Complete Response (pCR)
Time frame: Within 1 week after completion of radical cystectomy.
Defined as the absence of residual viable tumor cells (ypT0N0) in RC+PLND specimens. Assessed post-surgery. Method: A central pathology review committee performs centralized, blinded independent review of slides from all eligible patients. Sites ship de-identified slides and clinical forms to a central lab for uniform anonymization, QC, H\&E staining, and supplementary IHC if needed. All materials are fully de-identified, presented in random order without clinical data. Two senior uropathologists (associate professor level or above) read independently; consensus is final, otherwise a third senior pathologist adjudicates blindly. ypT and ypN are recorded.
1 secondary outcome
Incidence of Grade ≥3 Treatment-Related Adverse Events (TRAEs) During Neoadjuvant Therapy
Time frame: The period starting from the first administration of neoadjuvant therapy and extending through 4 weeks following the last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Results publication: PubMed 41193372Huang H, Ma W, Zeng X, Liu B, Dai H, Zhou G, Wan J, Zhang Y, Hu Z, Yang C. Efficacy and Safety of Disitamab Vedotin Combined with Gemcitabine as Neoadjuvant Therapy in Muscle-invasive Bladder Cancer: An Open-label, Multicenter, Single-arm, Phase 2 Trial. Eur Urol. 2026 Aug;90(2):103-107. doi: 10.1016/j.eururo.2025.10.009. Epub 2025 Nov 4.
- Results publication: PubMed 33109737Sheng X, Yan X, Wang L, Shi Y, Yao X, Luo H, Shi B, Liu J, He Z, Yu G, Ying J, Han W, Hu C, Ling Y, Chi Z, Cui C, Si L, Fang J, Zhou A, Guo J. Open-label, Multicenter, Phase II Study of RC48-ADC, a HER2-Targeting Antibody-Drug Conjugate, in Patients with Locally Advanced or Metastatic Urothelial Carcinoma. Clin Cancer Res. 2021 Jan 1;27(1):43-51. doi: 10.1158/1078-0432.CCR-20-2488. Epub 2020 Oct 27.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemcitabine, Toripalimab and Disitamab Vedotin (RC48) in people with MIBC, run by Zhiquan Hu at 22 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiquan Hu, M.D. (13971656164, huzhiquan2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: Within 1 week after completion of radical cystectomy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07693959, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.