Neoadjuvant Therapy in Cervical Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Disitamab Vedotin and Cisplatin: Disitamab Vedotin: 2mg/Kg,ivdrip, 3 weeks/cycle,3 cycles. Cisplatin: 75-80mg/m2, ivdrip, 3 weeks/cycle,3 cycles.

Study summary

In the comprehensive dataset of clinical diagnoses and treatments for cervical cancer in China, 49.8% of patients with stage IB3 and IIA2 receive surgical intervention following neoadjuvant chemotherapy. This indicates a pressing need to optimize neoadjuvant chemotherapy regimens for locally advanced cervical cancer. While paclitaxel combined with cisplatin is the conventional approach, 9.8% to 30.6% of patients demonstrate suboptimal responses, with a pathological complete response rate of approximately 10%.

Currently, the efficacy of antibody-drug conjugates in neoadjuvant chemotherapy for cervical cancer remains unexplored. This study seeks to address this gap by evaluating the combination of Disitamab Vedotin and Cisplatin in patients with stage IB3 and IIA2 cervical cancer with positive HER2 expression.The study will assess the impact of this regimen on pathological complete response rates, surgical complications, surgical resection rates, and overall survival.

Eligibility

Primary outcome measure(s)

• pathologic complete remission — At the end of Cycle 3 (each cycle is 21 days)
  The rate of patients with pathological examination revealed an absence of malignant cells.

Trial sites (1)

More Qilu Hospital of Shandong University trials in China

Other trials for the same condition