Cervical CancerPhase 2NCT04799639
Efficacy and Toxicity of Paclitaxel, Cisplatin Combined With Sindilimab in NACT for Locally Advanced Cervical Cancer
A Phase 2 study testing Sindilimab +paclitaxel+ cisplantin in people with Cervical Cancer and Chemotherapy Effect, run by Sun Yat-sen University at 1 site in China.
Trial summary
To determine the safety and efficacy of Sindilimab combined with Paclitaxel and Cisplatin in neoadjuvant chemotherapy for Locally Advanced Cervical Cancer Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Cancer, Chemotherapy Effect, Programmed Cell Death 1 Receptor / Antagonists & Inhibitors
- What is being tested?
- Sindilimab +paclitaxel+ cisplantin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2021to 24 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 65 years with primary cervical cancer;
- Clinical diagnosis of cervical cancer stage IB3 or IIA2 (FIGO stage, 2018). The stage was determined by two associate senior physicians or above after examining the patients;
- no distant organ metastasis, and the short diameter of retroperitoneal lymph nodes was less than 1 cm;
- according to the RECIST version 1.1 criteria, the measurable lesion of the cervix assessed by imaging was > 3.5 cm;
- histological types includes cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma;
- no radiotherapy, chemotherapy or targeted therapy before;
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- the expected survival time was greater than 3 months;
- the ECOG score of the Eastern Cooperative Oncology Group was 0 - 1;
- the function of important organs met the requirements of surgery, chemotherapy and radiotherapy.
Who cannot join
- Patients with other malignant tumors;
- Patients is pregnancy or in perinatal period;
- Patients with myocardial infarction or stroke, or unstable angina pectoris, decompensated heart failure, or deep venous thrombosis;
- Patients with NCI-CTCAE 5.0 ≥ grade 2 arrhythmia, any grade of atrial fibrillation, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
- Patients with active pneumonia: hepatitis patients with progressive loss of appetite, general weakness, nausea, acid reflux, anorexia, abdominal distension and other clinical manifestations, abnormal liver function and jaundice such as yellow eyes, yellow urine and other clinical symptoms;
- Patients with liver dysfunction (aspartate/alanine aminotransferase > 2.5 times the upper limit of the standard);
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- Patients with renal insufficiency (serum creatinine > 2 times the upper limit of the standard);
- History of chronic lung disease with restrictive respiratory dysfunction;
- History of important organ transplantation, history of immune diseases;
- History of severe mental illness, History of cerebral dysfunction;
- history of drug abuse or drug use;
- patients are using immunosuppressive agents, or systemic hormone therapy to achieve the purpose of immunosuppression (dose > 10 mg prednisone or other effective hormones), and continue to use 2 weeks before enrollment;
- coagulation abnormalities (INR > 2.0, PT > 16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy, allowing prophylactic use of low-dose aspirin,Low molecular weight heparin;
- Congenital or acquired immunodeficiency (such as HIV infection);
- Received live vaccine within 30 days before the first dose;
- Unable or unwilling to sign the informed consent form or comply with the study requirements;
- Have a history, disease or laboratory abnormalities that may interfere with the test results or prevent the subject from participating in the study, or the investigator believes that participating in the study is not in the best benefit of the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Toxicity of Paclitaxel, Cisplatin Combined With Sindilimab in Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
To determine the safety and efficacy of Sindilimab combined with Paclitaxel and Cisplatin in neoadjuvant chemotherapy for Locally Advanced Cervical Cancer
Read the detailed description
A total of 47 patients will be enrolled in this study. After screening, patients will receive intravenous drip of standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles. CT/MR of chest, upper and lower abdomen and pelvic MR will be performed before treatment and 2 weeks after the 3rd cycle chemotherapy. The objective response rate (ORR) (CR + PR) is evaluated by comparing with baseline based on RECISTv1.1. Radical surgery will be performed after NACT. According to the postoperative pathological results, the pathological complete remission rate (pCR) will be evaluated. The adverse events will be continuously monitored during treatment until 30 days after chemotherapy. Toxic adverse events is evaluated according to NCI-CTCAEv5.0 criteria.
- Conditions
- Cervical Cancer, Chemotherapy Effect, Programmed Cell Death 1 Receptor / Antagonists & Inhibitors, Neoadjuvant Therapy
- Being tested
- Sindilimab +paclitaxel+ cisplantin
- 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.
Sindilimab +paclitaxel+ cisplantinDrug
standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel + cisplantin + Sindilimab | Experimental | standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles paclitaxel 150mg/m2，ivdrip,>3 hours cisplantin 70mg/m2，ivdrip，>1 hours Sindilimab 200mg，ivdrip, >0.5 hours Receives: Drug: Sindilimab +paclitaxel+ cisplantin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete remission rate (pCR) rate
According to the postoperative pathological results, the pathological complete remission rate (pCR) will be evaluated.
Measured: 3 months
Secondary outcomes (1)
objective response rate (ORR) (CR + PR)
The objective response rate (ORR) (CR + PR) is evaluated by comparing with baseline based on RECISTv1.1.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start18 Mar 2021
- Primary completion17 Jun 2024
- Study completion24 Jun 2024
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.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- patients will receive intravenous drip of standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihong Liu, Sun Yat-sen University
- Investigators
- Jihong Liu, Ph.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799639
- Sponsor's protocol ID
- B2020-201-01
- Status last verified
- Jun 2024
- First submitted
- 14 Mar 2021
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Toxicity of Paclitaxel, Cisplatin Combined With Sindilimab in Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer
- ClinicalTrials.gov ID
- NCT04799639
- Acronym / sponsor ID
- B2020-201-01
- Conditions
- Cervical Cancer, Chemotherapy Effect, Programmed Cell Death 1 Receptor / Antagonists & Inhibitors, Neoadjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 16 Mar 2021 (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.
To determine the safety and efficacy of Sindilimab combined with Paclitaxel and Cisplatin in neoadjuvant chemotherapy for Locally Advanced Cervical Cancer
Detailed description
A total of 47 patients will be enrolled in this study. After screening, patients will receive intravenous drip of standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles. CT/MR of chest, upper and lower abdomen and pelvic MR will be performed before treatment and 2 weeks after the 3rd cycle chemotherapy. The objective response rate (ORR) (CR + PR) is evaluated by comparing with baseline based on RECISTv1.1. Radical surgery will be performed after NACT. According to the postoperative pathological results, the pathological complete remission rate (pCR) will be evaluated. The adverse events will be continuously monitored during treatment until 30 days after chemotherapy. Toxic adverse events is evaluated according to NCI-CTCAEv5.0 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients will receive intravenous drip of standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles
| Arm | Type | Receives |
|---|---|---|
| paclitaxel + cisplantin + Sindilimab | Experimental | Drug: Sindilimab +paclitaxel+ cisplantinstandard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles paclitaxel 150mg/m2，ivdrip,>3 hours cisplantin 70mg/m2，ivdrip，>1 hours Sindilimab 200mg，ivdrip, >0.5 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 18 to 65 years with primary cervical cancer;
- Clinical diagnosis of cervical cancer stage IB3 or IIA2 (FIGO stage, 2018). The stage was determined by two associate senior physicians or above after examining the patients;
- no distant organ metastasis, and the short diameter of retroperitoneal lymph nodes was less than 1 cm;
- according to the RECIST version 1.1 criteria, the measurable lesion of the cervix assessed by imaging was > 3.5 cm;
- histological types includes cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma;
Key exclusion criteria (17 listed)
- Patients with other malignant tumors;
- Patients is pregnancy or in perinatal period;
- Patients with myocardial infarction or stroke, or unstable angina pectoris, decompensated heart failure, or deep venous thrombosis;
- Patients with NCI-CTCAE 5.0 ≥ grade 2 arrhythmia, any grade of atrial fibrillation, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
- Patients with active pneumonia: hepatitis patients with progressive loss of appetite, general weakness, nausea, acid reflux, anorexia, abdominal distension and other clinical manifestations, abnormal liver function and jaundice such as yellow eyes, yellow urine and other clinical symptoms;
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 |
|---|---|---|
| Sindilimab +paclitaxel+ cisplantinstandard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles | Drug | paclitaxel + cisplantin + Sindilimab |
Primary outcome
pathological complete remission rate (pCR) rate
Time frame: 3 months
According to the postoperative pathological results, the pathological complete remission rate (pCR) will be evaluated.
1 secondary outcome
objective response rate (ORR) (CR + PR)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jihong Liu, Ph.D. principal investigator
Sun Yat-sen 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 Sindilimab +paclitaxel+ cisplantin in people with Cervical Cancer and Chemotherapy Effect, run by Sun Yat-sen University 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 9 inclusion and 17 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: finished, as of the sponsor's last update on 25 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete remission rate (pCR) rate (time frame: 3 months). 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 25 Jun 2024.