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CompletedNCT04799639Updated Jun 25, 2024

Efficacy and Toxicity of Paclitaxel, Cisplatin Combined With Sindilimab in NACT for Locally Advanced Cervical Cancer

A Phase 2 interventional study of Sindilimab +paclitaxel+ cisplantin in Cervical Cancer, Chemotherapy Effect and Programmed Cell Death 1 Receptor / Antagonists & Inhibitors, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-25.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
47
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Cervical Cancer
  • Chemotherapy Effect
  • Programmed Cell Death 1 Receptor / Antagonists & Inhibitors
  • Neoadjuvant Therapy
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 47 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients aged 18 to 65 years with primary cervical cancer;
  2. 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;
  3. no distant organ metastasis, and the short diameter of retroperitoneal lymph nodes was less than 1 cm;
  4. according to the RECIST version 1.1 criteria, the measurable lesion of the cervix assessed by imaging was > 3.5 cm;
  5. histological types includes cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma;
  6. no radiotherapy, chemotherapy or targeted therapy before;
  7. the expected survival time was greater than 3 months;
  8. the ECOG score of the Eastern Cooperative Oncology Group was 0 - 1;
  9. the function of important organs met the requirements of surgery, chemotherapy and radiotherapy.

Exclusion criteria

Exclusion Criteria:

  1. Patients with other malignant tumors;
  2. Patients is pregnancy or in perinatal period;
  3. Patients with myocardial infarction or stroke, or unstable angina pectoris, decompensated heart failure, or deep venous thrombosis;
  4. 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;
  5. 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;
  6. Patients with liver dysfunction (aspartate/alanine aminotransferase > 2.5 times the upper limit of the standard);
  7. Patients with renal insufficiency (serum creatinine > 2 times the upper limit of the standard);
  8. History of chronic lung disease with restrictive respiratory dysfunction;
  9. History of important organ transplantation, history of immune diseases;
  10. History of severe mental illness, History of cerebral dysfunction;
  11. history of drug abuse or drug use;
  12. 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;
  13. 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;
  14. Congenital or acquired immunodeficiency (such as HIV infection);
  15. Received live vaccine within 30 days before the first dose;
  16. Unable or unwilling to sign the informed consent form or comply with the study requirements;
  17. 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    paclitaxel + cisplantin + Sindilimab

    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

    Drug: Sindilimab +paclitaxel+ cisplantin

Interventions

  • DrugSindilimab +paclitaxel+ cisplantin

    standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles

06

What researchers measure

Primary outcomes

  1. pathological complete remission rate (pCR) rate

    According to the postoperative pathological results, the pathological complete remission rate (pCR) will be evaluated.

    Time frame: 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.

    Time frame: 3 months

07

Study locations

1 site
  • Sun Yat-sen University cancer center
    Guangzhou, Guangdong 510000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04799639
Lead sponsor
Sun Yat-sen University
Responsible party
Jihong Liu (Professor, Sun Yat-sen University) — Principal investigator
First posted
Mar 16, 2021
Start date
Mar 18, 2021
Primary completion
Jun 17, 2024
Completion
Jun 24, 2024
Last update
Jun 25, 2024

Study contacts

Jihong Liu, Ph.D.
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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