Health TrialsbyHealthPanel

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

ConditionCervical Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sintilimab

    Drug

    neoadjuvent chemotherapy plus sintilimab for 2 cycles followed by radical surgery

  • Concurrent chemo-radiotherapy

    Radiation

    EBRT+BT+cisplatin

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: neoadjuvent armExperimental treatment 1 intervention
Group B: CCRT armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

2-year Progression-Free Survival Rate

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: