Vedisertib (RC48/ADC) Combined With Toripalimab in Bladder-preserving Treatment
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Hospital of Shandong University
About this trial
This is a phase II clinical study to evaluate the efficacy of RC48-ADC combined with toripalimab bladder-sparing therapy.
The RC48-ADC dose in this study is 2.0 mg/kg Q2W and toripalimab is 3 mg/kg Q2W.
This study plans to enroll 59 participants. The participants will start drug therapy within 2 weeks after the first diagnostic resection in the first stage, receiving RC48-ADC combined with toripalimab 3 times. At the 8th week after enrollment, the second stage of cystectomy was performed, and RC48-ADC combined with toripalimab was treated every two weeks thereafter for a total of 3 treatments. After the completion of the two-stage treatment, the participants should be discharged from the group by cystoscopy or other imaging examinations. On the contrary, if the participants have complete remission or partial remission, continue to the third stage of treatment, that is, receive RC48-ADC combined with toripalimab every two weeks for a total of 6 treatments, followed by cystoscopy, imaging, or a third cystectomy. If the participants achieve complete remission of the disease, maintenance immunotherapy will be given for 12 months. If the participants show that there is still a tumor, the participants will be discharged from the group for other treatments. Due to disease progression, death, participants voluntarily requested termination of study treatment, toxicity intolerance, initiation of new anti-tumor therapy, pregnancy, serious violation of the study process stipulated by the protocol, termination of study treatment determined by the investigator based on the best interests of the participants, loss to follow-up, whichever occurred first.
During the study, the first and second electrotoxic tissues were sequenced using RNA and single-cell sequencing, and ctDNA was tested in urine before treatment, in the third month, and in the sixth month.
Eligibility criteria
Qualifiers
Voluntarily agree to participate in the study and sign the informed consent form;
Male or female, age ≥ 18 years;
Expected survival ≥ 18 months;
Pathological and imaging diagnosis of cT2-4aN0M0MIBC;
Disqualifiers
Patients have received potentially curative therapy and no evidence of the disease within 5 years;
Successfully undergoing resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, and other carcinomas in situ;
Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.);
Previous allogeneic stem cell or parenchymal organ transplantation; Patients who have received other anti-tumor systemic therapy (including traditional Chinese medicine with anti-tumor indications) in the past, less than 4 weeks after the completion of treatment to before the use of this study, or who have not recovered to ≤ CTCAE grade 1 (except for alopecia and pigmentation);
Trial design
Treatments tested in this trial
- RC48-ADC combined with toripalimab for bladder-sparing therapy
Treatment groups
59 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov