Clinical trial NCT06558682: Neoadjuvant Therapy in Cervical Cancer
Official title: Disitamab Vedotin Combined With Cisplatin for Neoadjuvant Therapy in Locally Advanced Cervical Cancer: a Prospective, Single-arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uterine Cervical Neoplasms
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: RemeGen Co., Ltd.
First posted: 2024-08-19
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Primary research objectives:

To evaluate the effect of Disitamab Vedotin combined with cisplatin on pathological response rate (pCR) of locally advanced cervical cancer.

Secondary research objectives:

1. To evaluate the safety of Disitamab Vedotin combined with cisplatin;
2. To evaluate the effects of Disitamab Vedotin combined with cisplatin on surgical complications, surgical clearance rate and postoperative adjuvant treatment ratio;
3. To evaluate the effects of Disitamab Vedotin combined with cisplatin on objective tumor response rate (ORR), disease control rate (DCR) and survival;

Exploratory research objectives:

To explore the changes of tumor tissue protein expression, immune factors and HER-2 receptor expression before and after the use of ADC drugs, as well as biomarkers that can effectively predict the therapeutic effect.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of cervical squamous cell carcinoma
* HER-2 positive

Exclusion Criteria:

* Cervical adenocarcinoma

Primary outcomes:
measure: pathologic complete remission
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
Secondary outcomes:
measure: Objective Response Rate
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Kun Song
role: PRINCIPAL_INVESTIGATOR
References:
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