Clinical trial NCT05872724: Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD(Minimal Residual Disease)
Official title: Clinical Study on Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cervical Cancer
Lead sponsor: Suzhou Municipal Hospital
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cohort study
Primary purpose: TREATMENT

Brief summary: This study is a prospective cohort clinical trial that aims to investigate the safety and efficacy of a combined chemoradiotherapy and immunotherapy treatment for early postoperative cervical cancer. Specifically, this study seeks to evaluate the ability of MRD-based screening to detect and monitor changes in MRD status at different stages of treatment, its potential for use in monitoring patient recurrence rates and in prognosis evaluation. In addition, this study will investigate the safety and effectiveness of chemoradiotherapy combined with immunotherapy as a postoperative adjuvant therapy for patients identified to be at risk of early cervical cancer based on MRD screening.

Detailed description: The study comprised of three periods; a screening period (within 28 days prior to informed consent), a treatment period (defined as the time from the initiation of treatment to its termination for any reason), and a follow-up period (consisting of end-of-treatment visits, safety visits, and survival follow-up). During the screening period, participants underwent eligibility evaluations, including tissue and blood sample collection for biomarker detection. Eligible subjects were divided into high-risk and intermediate-risk groups based on Peter's criteria and Sedlis criteria, with patients in the high-risk group or those identified as MRDc0 (+) (3 days after surgery to 10 days before adjuvant therapy) receiving conventional pelvic concurrent chemoradiotherapy, adjuvant chemotherapy, and four courses of immunotherapy. Patients in the intermediate-risk group and those identified as MRDc0 (-) received simultaneous chemoradiotherapy in the target volume of the small pelvis, four courses of immunotherapy, continued immunotherapy with MRDIn(+)(2 months after initiation of immunotherapy), and follow-up monitoring with MRDIn(-). Subjects returned to the hospital for a safety follow-up 28 days (±7d) after the last dose to track the outcome of adverse events. Safety visits consisted of vital sign measurements, laboratory tests, and other protocol-required assessments to evaluate adverse events, concomitant medications, and concomitant therapy. At the end of treatment, subjects began survival follow-up every 3 months (±7d). Radiographic assessments were conducted at this frequency until disease progression, death, loss of follow-up, withdrawal of informed consent, initiation of follow-up antitumor therapy, or investigator-initiated termination of the study.

Eligibility criteria: Inclusion Criteria:

1. Patients with histopathological and clinical (FIGO 2018) stage ⅠB2 \~II A2 cervical cancer.
2. Above the age of 18.
3. General status: ECOG score 0-2.
4. Be able to understand the research scheme, voluntarily participate in the study, and sign the informed consent.
5. Good compliance, able to cooperate with the collection of specimens at each node and provide corresponding clinical information.

Exclusion Criteria:

1. Suffering from other malignant tumors.
2. Do not receive the specified treatment or change the treatment regimen before the disease progresses.
3. The study cannot be followed up according to the defined clinical follow-up period.
4. Unable to accept or provide CT or other designated therapeutic evaluation means.
5. Have an autoimmune disease.

Primary outcomes:
measure: 3-year DFS in ITT population (intent-to-treat population)
timeFrame: 3-year
Secondary outcomes:
measure: 3-year DFS with different MRD status and changes
timeFrame: 3-year
measure: 2-year DFS with different MRD status and changes
timeFrame: 2-year
measure: 1-year DFS with different MRD status and changes
timeFrame: 1-year
measure: 3-year OS rates in patients with different MRD status and changes
timeFrame: 3-year
measure: AE
timeFrame: Up to 28 days after the end of treatment
Other outcomes:
measure: Disease recurrence based on MRD monitoring methods
timeFrame: through study completion, an average of 3-6 months
measure: Negative conversion rate of MRD (+) patients after intensive adjuvant therapy
timeFrame: through study completion, an average of 3-6 months
measure: To explore the correlations of genes detected by next-generation sequencing, MRI-based response patterns and biomarkers of peripheral blood with the efficacy of treatment.
timeFrame: 3-year
Locations:
city: Suzhou
country: China
facility: The Affiliated Suzhou Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Affiliated Suzhou Hospital of Nanjing Medical University
name: jing xue
role: PRINCIPAL_INVESTIGATOR
References: