Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD(Minimal Residual Disease)

NCT05872724 | Recruiting Phase 2

• 1 other identifier: Optimize
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year DFS in ITT population (intent-to-treat population)

  DFS (disease-free survival) is the time between the start of enrollment and the recurrence of disease, or death from any cause.

  3-year

Secondary Outcomes (5)

• 3-year DFS with different MRD status and changes

  3-year

• 2-year DFS with different MRD status and changes

  2-year

• 1-year DFS with different MRD status and changes

  1-year

• 3-year OS rates in patients with different MRD status and changes

  3-year

• AE

  Up to 28 days after the end of treatment

Other Outcomes (3)

• Disease recurrence based on MRD monitoring methods

  through study completion, an average of 3-6 months

• Negative conversion rate of MRD (+) patients after intensive adjuvant therapy

  through study completion, an average of 3-6 months

• 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.

  3-year

Study Arms (2)

Arm A

EXPERIMENTAL

Eligible subjects were assigned to high-risk or medium-risk groups based on Peter's criteria and Sedlis criteria. Patients with a high-risk classification or MRDc0 (+) status received a treatment consisting of conventional pelvic concurrent chemoradiotherapy, adjuvant chemotherapy, four courses of immunotherapy, continued immunotherapy with MRDIn(+), and follow-up monitoring with MRDIn(-)

Drug: Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab

Arm B

EXPERIMENTAL

Patients deemed intermediate risk and with MRDc0 (-) status received concurrent chemoradiotherapy in the small pelvic target volume, four courses of immunotherapy, continued immunotherapy with MRDIn(+), and follow-up monitoring with MRDIn(-)

Drug: Chemoradiotherapy (small pelvic) + Zimberelimab

Interventions

Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab DRUG

* 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 A

Chemoradiotherapy (small pelvic) + Zimberelimab DRUG

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 B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Municipal Hospital: lead

Study Sites (1)

The Affiliated Suzhou Hospital of Nanjing Medical University

Suzhou, Jiangsu, 215001, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Chemoradiotherapy; Chemotherapy, Adjuvant; zimberelimab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• jing xue

  The Affiliated Suzhou Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jing xue

CONTACT

(+86)13771734347; jxue@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Model Details: cohort study

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 24, 2023
• Study Start: January 16, 2023
• Primary Completion (Estimated): January 16, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)