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Not yet recruitingNCT07088731Updated Sep 22, 2025

Clinical Study to Evaluate the Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin and Sintilimab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer

A Phase 2 interventional study of Sintilimab and Concurrent chemo-radiotherapy in Cervical Carcinoma, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

For locally advanced cervical cancer, there are two main treatment options:

One is radical chemoradiotherapy (a combination of radiotherapy and chemotherapy aimed at curing the disease).

The other is having neoadjuvant treatment first (treatment given before the main surgery to shrink the tumor) followed by radical surgery.

So far, there's no clear answer on which of these two options is better. In general, cervical cancer responds well to immunotherapy. But we still don't know for sure if adding immunotherapy to neoadjuvant chemotherapy can improve the treatment effect for locally advanced cervical cancer, or even make it better than radical chemoradiotherapy.

This study aims to compare the effects of two approaches: radical chemoradiotherapy versus neoadjuvant chemotherapy plus immunotherapy followed by surgery.

02

Conditions studied

  • Cervical Carcinoma

Keywords

  • locally advanced
  • neoadjuvent chemotherapy
  • neoadjuvent immunotherapy
  • CCRT
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 planned enrollment of 180 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Aged ≥ 18 years and ≤ 70 years;
  • Cervical cancer with pathological types being squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;
  • Staged IB3 or IIA2 according to the FIGO 2018 staging system, as assessed by the investigator;
  • ECOG performance status of 0-2, or KPS score ≥ 70;
  • Expected survival time of more than 3 months;
  • Having at least one measurable lesion in accordance with RECIST 1.1;
  • Laboratory test results meeting the following criteria without drug intervention:

    1. Hemoglobin ≥ 90 g/dl, neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L;
    2. Creatinine ≤ 1.5 times the upper limit of normal range;
    3. Total bilirubin, alanine transaminase (ALT), and aspartate transaminase (AST) \< 2 times the upper limit of normal;
  • Postmenopausal, or reproductive-aged women who meet all the following conditions: non-lactating, not pregnant, and able to use effective contraceptive measures during the study treatment period;
  • Voluntarily participating in this study and signing the informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Participated in other clinical trials within 30 days before receiving the first dose of chemotherapy drugs or during the treatment period.
  • Previously received any other anti-tumor treatment for cervical cancer.
  • Non-HPV-related cervical cancer.
  • Needing to receive other anti-tumor treatments during the study treatment period.
  • Patients with known allergies to the active ingredients of the study drugs or their excipients.
  • Diagnosed with other malignant tumors in the past 5 years (except those judged to be cured by the investigator).
  • Active infections requiring systemic treatment.
  • Positive for human immunodeficiency virus (HIV) antibody.
  • Positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody.
  • Peripheral neuropathy with a grade of ≥ 2 according to the NCI-CTCAE (Version 5.0).
  • Concurrent diseases or abnormal test results that interfere with the subject's ability to receive anti-tumor treatment as judged by the investigator, such as the estimated inability of the subject to tolerate at least 2 cycles of neoadjuvant chemotherapy plus surgery or concurrent chemoradiotherapy, etc.

Participation in this study is deemed not conducive to the maximum benefit of the subject as judged by the investigator.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    neoadjuvent arm

    Drug: Sintilimab

  • Active comparator
    CCRT arm

    Radiation: Concurrent chemo-radiotherapy

Interventions

  • DrugSintilimab

    neoadjuvent chemotherapy plus sintilimab for 2 cycles followed by radical surgery

    Also known as: Nab-paclitaxel, cisplatin

  • RadiationConcurrent chemo-radiotherapy

    EBRT+BT+cisplatin

06

What researchers measure

Primary outcomes

  1. 2-year Progression-Free Survival Rate

    Time frame: From enrollment to the end of treatment at 2 years

07

Study locations

1 site
  • Department of Gynecological Oncology
    Beijing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07088731
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Responsible party
GUANG WEN YUAN (Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Jul 28, 2025
Start date
Sep 2025 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Sep 22, 2025

Study contacts

Guangwen Yuan, doctoral
Contact
william327@126.com
+86 136 9368 4116

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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