Cervical CancerPhase 2NCT05872724
Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD(Minimal Residual Disease)
A Phase 2 study testing Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab and Chemoradiotherapy (small pelvic) + Zimberelimab in people with Cervical Cancer, run by Suzhou Municipal Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab and Chemoradiotherapy (small pelvic) + Zimberelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2023to 30 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Suzhou Hospital of Nanjing Medical University
Suzhou, Jiangsu, 215001
Jing Xue, 13771734347, jxue@njmu.edu.cn
About this study
Official title: Clinical Study on Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD
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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab, Chemoradiotherapy (small pelvic) + Zimberelimab
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemoradiotherapy + Adjuvant chemotherapy and ZimberelimabDrug
- Radiation therapy:
- 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:
- 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 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.
Chemoradiotherapy (small pelvic) + ZimberelimabDrug
Radiation therapy:
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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(-) Receives: 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(-) Receives: Drug: Chemoradiotherapy (small pelvic) + Zimberelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-year
Secondary outcomes (5)
3-year DFS with different MRD status and changes
DFS (disease-free survival) is the time between the start of enrollment and the recurrence of disease, or death from any cause
Measured: 3-year
2-year DFS with different MRD status and changes
DFS (disease-free survival) is the time between the start of enrollment and the recurrence of disease, or death from any cause
Measured: 2-year
1-year DFS with different MRD status and changes
DFS (disease-free survival) is the time between the start of enrollment and the recurrence of disease, or death from any cause
Measured: 1-year
3-year OS rates in patients with different MRD status and changes
OS (overall survival) is the overall time from enrollment to death from any cause
Measured: 3-year
AE
Adverse events (AE) were determined and graded according to NCI CTC AE 5.0, Collect the incidence of adverse events (AEs), the incidence of serious adverse events (SAEs), the incidence of CTCAE grade 3 or above (rated based on CTCAE 5.0), the correlation of adverse events, actions taken and outcomes, etc.
Measured: Up to 28 days after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start16 Jan 2023
- Primary completion16 Jan 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- cohort study
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jing xue, Suzhou Municipal Hospital
- Investigators
- jing xue, Principal investigator, The Affiliated Suzhou Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872724
- Sponsor's protocol ID
- Optimize
- Status last verified
- May 2023
- First submitted
- 12 Apr 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: CRF (Case Report Form) and ICF (Informed Consent Form) will be shared in the future
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD
- ClinicalTrials.gov ID
- NCT05872724
- Acronym / sponsor ID
- Optimize
- Conditions
- Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Suzhou Municipal HospitalUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 16 Jan 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cohort study
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Chemoradiotherapy + Adjuvant chemotherapy and ZimberelimabEligible 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(-) |
| Arm B | Experimental | Drug: Chemoradiotherapy (small pelvic) + ZimberelimabPatients 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(-) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab* 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. | Drug | Arm A |
| Chemoradiotherapy (small pelvic) + ZimberelimabRadiation 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. | Drug | Arm B |
Primary outcome
3-year DFS in ITT population (intent-to-treat population)
Time frame: 3-year
DFS (disease-free survival) is the time between the start of enrollment and the recurrence of disease, or death from any cause.
5 secondary outcomes
3-year DFS with different MRD status and changes
Time frame: 3-year
2-year DFS with different MRD status and changes
Time frame: 2-year
1-year DFS with different MRD status and changes
Time frame: 1-year
3-year OS rates in patients with different MRD status and changes
Time frame: 3-year
AE
Time frame: Up to 28 days after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No. CRF (Case Report Form) and ICF (Informed Consent Form) will be shared in the future
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
jing xue principal investigator
The Affiliated Suzhou Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab and Chemoradiotherapy (small pelvic) + Zimberelimab in people with Cervical Cancer, run by Suzhou Municipal Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jing xue ((+86)13771734347, jxue@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year DFS in ITT population (intent-to-treat population) (time frame: 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.