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Trial Title:
Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD(Minimal Residual Disease)
NCT ID:
NCT05872724
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
cohort study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab
Description:
- Radiation therapy:
1. Irradiation mode and dose: 6MV-X-ray (6Megavoltage-X-ray), IMRT or
RapidArc-IMRT were used for external radiotherapy. External radiotherapy dose:
PTV (Planning Target Volume) 45-50Gy/25 times.
- Chemotherapy:
1. Concurrent chemotherapy: Cisplatin monotherapy: DDP 75 mg/m2 for 3 days, q3w.
Carboplatin or nedaplatin may be used in patients that cannot tolerate
cisplatin.
2. Adjuvant chemotherapy: After the concurrent chemoradiotherapy, 4 cycles of
consolidation chemotherapy plus immunotherapy are recommended for patients with
high risk or MRDc0 (+). Recommended chemotherapy regimen: liposome paclitaxel
135mg/m2 d1 +DDP 25 mg/m2 D1-3, Q21.
- Zimberelimab injection:
240 mg, IV, q3w. Start the drug one day before the start of postoperative
radiotherapy.
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Chemoradiotherapy (small pelvic) + Zimberelimab
Description:
Radiation therapy:
1. Target volume of radiotherapy for small pelvis: CTVp includes tumor bed area,
paracentral area and part of vagina; CTVn includes bilateral internal iliac,
external iliac and obturator lymphatic drainage areas. Upper boundary to sacroiliac
joint level, lower boundary to 2cm below vaginal stump.
Chemotherapy:
Concurrent chemotherapy: Cisplatin monotherapy: DDP 75 mg/m2 for 3 days, q3w. Carboplatin
or nedaplatin may be used in patients that cannot tolerate cisplatin.
Adjuvant chemotherapy: After the concurrent chemoradiotherapy, 4 cycles of adjuvant
immunotherapy are recommended for patients in good general condition (ECOG: 0-1) with
medium risk and MRDc0 (-).
Zimberelimab injection: 240 mg, IV, q3w. Start the drug one day before the start of
posterior radiotherapy.
Arm group label:
Arm B
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Affiliated Suzhou Hospital of Nanjing Medical University
Address:
City:
Suzhou
Zip:
215001
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Xue
Phone:
13771734347
Email:
jxue@njmu.edu.cn
Start date:
January 16, 2023
Completion date:
December 30, 2028
Lead sponsor:
Agency:
Suzhou Municipal Hospital
Agency class:
Other
Source:
Suzhou Municipal Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05872724
