A Phase 2 interventional study of Disitamab vedotin and Tislelizumab in Colorectal Neoplasms, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-21.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment
Among patients with colonrectal cancer, 5% were HER-2 positive, but the immunohistochemical results were mostly HER-2 2 +, which did not meet the indications of HER-2 targeting drugs. Disitamab Vedotin , which was listed in China last year, achieved similar results in HER-2 2+ and 3+, according to a clinical trial for breast cancer, suggesting that patients with colonrectal cancer may benefit from it. Tislelizumab is a PD-1 monoclonal antibody, which has been approved for a variety of tumors. It was reported that anti-HER-2 treatment can improve the tumor immune microenvironment and improve the efficacy of immunotherapy. At the same time, our previous studies showed that anti-PD-1 combined with Disitamab Vedotin can significantly inhibit the growth of colon tumor in mice. Therefore, Disitamab Vedotin and Tislelizumab were used in this study. This prospective clinical trial may bring new hope for the treatment of HER-2 positive CRC patients.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's planned enrollment of 29 is below the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Have sufficient heart, lung, liver and kidney functions, and the laboratory examination within 14 days before screening meets the following indicators:
i. Hemoglobin Hb ≥ 90 g/L ii. Neutrophil count ANC ≥ 1.5*10\^9 /L iii. Platelet count PLT ≥ 80*10\^9 /L iv. Albumin ALB ≥ 35 g/L v. Alanine aminotransferase ALT and aspartate aminotransferase AST ≤ 2.5 times the upper limit of the normal range, and liver metastasis patients ≤ 5 times the upper limit of the normal range.
vi. Total bilirubin ≤ 1.5 times, or 2 times the upper limit of normal. vii. Creatinine Scr ≤ upper limit of normal range. viii. Prothrombin: PT-INR ≤ 2.3 or PT \< 6 seconds compared with normal control
Exclusion Criteria:
Disitamab Vedotin 2.0mg/kg q2w+Tislelizumab 400mg q6w. The treatment of Disitamab Vedotin + Tislelizumab will continue until the tumor progression confirmed by imaging, or up to 2 years, or intolerable toxic reactions, or other conditions determined by the researchers.
Drug: Disitamab vedotin · Drug: Tislelizumab
2.0mg/kg，q2w
Also known as: RC48
400mg，q6w
Objective response rate(ORR)
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
Time frame: up to 2 years
Progression-free Survival(PFS)
PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.
Time frame: From date of subjects until the date of first documented progression or death from any cause, whichever came first, assessed up to 24 months
Overall Survival (OS)
OS is defined as the time from date of assignment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time frame: From assignment of the first subject until 32 death events observed, up to 2 years.
Disease control rate (DCR)
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD).
Time frame: up to 2 years
Safety and Feasibility
Safety is defined as the incidence of Grade 3-4 Treatment-Related Adverse Events (TRAEs) from the day of neoadjuvant therapy to 30 days after surgery or within 90 days after last neoadjuvant treatment. Feasibility of surgery is defined as the incidence of TRAEs causing surgery delay of ≥30 days and/or inoperable patients.Feasibility of surgery is defined as the incidence of TRAEs causing surgery delay of ≥30 days and/or inoperable patients.
Time frame: up to 2 years
Duration of Response (DOR)
DOR is defined as the time from randomization to disease progression or death in patients who achieve complete or partial response.
Time frame: up to 2 years
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The First Affiliated Hospital with Nanjing Medical University