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โ† Trials
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Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors

RecruitingPhase 2Ages 18 Years - 65 YearsAllTianjin Medical University Cancer Institute and Hโ€ฆ
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In plain words

What the trial is, and whether it could suit you

A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk Factors

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Voluntarily participate in the clinical study: Fully understand and be informed about the study, and sign the informed consent form (ICF); willing to comply with and capable of completing all trial procedures. * Female aged โ‰ฅ18 years and โ‰ค65 years at the time of signing the ICF. * ECOG PS score of 0 or 1. * Positive PD-L1 status (CPS โ‰ฅ1). * Diagnosed with cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. * FIGO (International Federation of Gynecology and Obstetrics) stage of IB1, IB2, IIA1, or IIA2, and patients judged by the investigator to benefit from radical surgery and/or adjuvant therapy. * Have undergone radical hysterectomy (Piver classification) and pelvic lymphadenectomy of type II or III. * Postoperative pathological examination confirms at least two adverse factors, which may include: Lymph node metastasis; Positive parametrial or positive resection margins; Lymphovascular space invasion; Deep stromal invasion; * Patients must meet the following hematological, renal, and liver function criteria: Absolute neutrophil count of at least 1.5 ร— 10โน/L; Platelet count of at least 100 ร— 10โน/L; Total bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels not exceeding 1.5 times the upper limit of normal; Creatinine levels not exceeding the upper limit of normal. * Female participants must have a negative serum pregnancy test within 14 days prior to treatment and agree to use effective contraception during the treatment period and for 6 months afterward; breastfeeding is prohibited during treatment. * Willing and able to comply with the trial and follow-up procedures. Exclusion Criteria: * Patients with unresectable residual tumors. * Histologically confirmed diagnosis of cervical small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma. * Patients who have previously received pelvic radiotherapy. * History of other untreated malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ. * Presence of any active or known autoimmune disease. * History of inflammatory/autoimmune diseases requiring steroid treatment, or currently suffering from inflammatory/autoimmune diseases that require steroid treatment. * Diseases requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization. * History of thromboembolic events (venous or arterial) occurring within 6 months prior to enrollment. * Poorly controlled clinical symptoms or conditions related to heart disease.
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What it tests

  • Serplulimab
  • Chemotherapy
  • radiotherapy
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Where

1 site
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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