Clinical trial NCT07003620: Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer:
        a Prospective, Single-arm, Phase II Clinical Trial
Official title: Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer:
        a Prospective, Single-arm, Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cervical Cancers
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm, Phase II clinical trial designed to evaluate the efficacy and safety of paclitaxel and carboplatin combined with PD-1/PD-L1 immune checkpoint inhibitors in the treatment of locally advanced cervical cancer. Using single-cell RNA sequencing (scRNA-seq), the study aims to investigate the molecular mechanisms underlying differential treatment responses and optimize personalized therapeutic strategies.

Eligibility Criteria:

Patients with locally advanced cervical cancer (FIGO stages IB3 to IIB) and a primary tumor diameter \>4 cm will be enrolled. All patients must have histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or common adenocarcinoma, an ECOG performance status of 0-1, and no prior treatment.

Outcome Measures:

* Primary endpoint: Objective response rate (ORR), assessing tumor regression.
* Secondary endpoints:Overall survival (OS), progression-free survival (PFS), and incidence of treatment-related adverse events (graded by CTCAE criteria).
* Exploratory endpoint:\*\* Impact of treatment on the tumor microenvironment and gene expression profiles.

Study Intervention:

All patients will receive three cycles of paclitaxel and carboplatin chemotherapy combined with PD-1/PD-L1 inhibitor therapy, followed by open radical hysterectomy and pelvic lymphadenectomy. Postoperative adjuvant therapy (chemotherapy, chemoradiation, or maintenance immunotherapy) will be determined based on pathological assessment. Tumor tissue samples will be collected during treatment for single-cell sequencing analysis.

Sample Size:

The study plans to enroll at least 34 eligible patients. Based on treatment response, patients will be categorized into high-response and low-response groups, with a minimum of 5 cases per group selected for scRNA-seq to ensure robust molecular mechanism analysis. The sample size calculation assumes a historical ORR of 65% and a target ORR of 85%.


Eligibility criteria: Inclusion Criteria:

* Patients with locally advanced cervical cancer (FIGO stages IB3 to IIB) and a primary tumor diameter \>4 cm will be enrolled.
* All patients must have histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or common adenocarcinoma.
* ECOG performance status of 0-1.
* no prior treatment.

Exclusion Criteria:

* Patients with a history of other malignant tumors in the past.
* Patients whose clinical data or treatment information is incomplete.
* Patients with severe comorbidities or those who cannot complete follow-up.

Primary outcomes:
measure: Objective response rate
timeFrame: 3 months post-treatment
Secondary outcomes:
measure: Overall survival
timeFrame: From the initiation of treatment (first dose of neoadjuvant immunochemotherapy) until the date of death from any cause), assessed up to 3 years
measure: progression-free survival
timeFrame: From the initiation of treatment (first dose of neoadjuvant immunochemotherapy) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
measure: incidence of treatment-related adverse events
timeFrame: From the initiation of treatment until 30 days after the last dose of neoadjuvant immunochemotherapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou
state: Guangdong
Study officials:
References: