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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvent arm | Experimental |
| |
| CCRT arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | neoadjuvent chemotherapy plus sintilimab for 2 cycles followed by radical surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year Progression-Free Survival Rate | From enrollment to the end of treatment at 2 years |
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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:
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:
Participation in this study is deemed not conducive to the maximum benefit of the subject as judged by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guangwen Yuan, doctoral | Contact | +86 136 9368 4116 | william327@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecological Oncology | Beijing | China |
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| Concurrent chemo-radiotherapy | Radiation | EBRT+BT+cisplatin |
|
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C520255 | 130-nm albumin-bound paclitaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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