RC48 Combined With Toripalimab as Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhujiang Hospital
About this trial
A single-arm, prospective, exploratory clinical trial to explore the pathological complete response (pCR) rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of platinum-intolerant bladder cancer patients. Fifty-five patients with clinically or pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC) who were ineligible for cisplatin-based chemotherapy or refused cisplatin-based chemotherapy were enrolled. Each subject will receive RC48-ADC and toripalimab intravenously every 2 weeks for a total of 4 cycles before surgery, 8 cycles after surgery. The efficacy was evaluated and followed up after 4 cycles of neoadjuvant therapy, 3 months postoperative, and every 3-6 months thereafter. The primary endpoint of this study was pathological complete response rate (pCR). The secondary endpoints were to explore the safety, disease-free survival (DFS), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) of RC48 combined with toripalimab neoadjuvant therapy followed by radical cystectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily agree to provide written informed consent.
Male or female, aged ≥18 years old.
Patients must be medically suitable for TURBT and RC.
Pathological examination and immunohistochemical Her-2 (≥1+)
Disqualifiers
known hypersensitivity to components of recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate or allergic reaction to toripalimab.
toxicity from previous antineoplastic therapy did not revert to CTCAE grade 0-1 (except grade 2 alopecia).
pleural or abdominal effusion with clinical symptoms requiring ongoing treatment.
history of major surgery within 4 weeks of planned initiation of trial treatment.
Trial design
Design model
Single group
Treatments tested in this trial
DisitamabVedotinForIicction Toripalimab
DrugEach subject will receive RC48-ADC 2.0mg/kg and toripalimab 3.0mg/kg intravenously every 2 weeks for a total of 4 cycles. RC48-ADC 2.0mg/kg and toripalimab 3.0mg/kg were intravenously infused every 2 weeks for 8 cycles.
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PcR
The resected primary tumor specimen and all sampled regional lymph nodes (ypT0N0) had no viable tumor cells.
Time frame
2monthsSponsors and contacts
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Source ClinicalTrials.gov