Treatment for advanced cervical cancer using chemoradiotherapy and immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and effectiveness of a treatment regimen combining Albumin-Bound Paclitaxel and cisplatin with concurrent chemoradiotherapy, followed by the PD-1 inhibitor Sintilimab in patients with locally advanced cervical cancer. Participants will receive weekly doses of the chemotherapeutic agents during radiation therapy, followed by eight cycles of Sintilimab administered every three weeks. The goal is to assess how well this combination works in treating the cancer and to monitor any potential side effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age between 18 and 75;
2. Untreated patients with pathologically proven locally advanced cervical cancer;
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
4. Adequate hematological, renal and hepatic functions:

   4.1 Hemoglobin \> 8.0 g/dl 4.2 Neutrophils \> 2000 cells/μl; Leukocytes \> 4 × 109/L 4.3 Platelets \> 100 × 109/Lg. 4.4 Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) 4.5 Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) 4.6 Serum ALT/AST ≤ 2.5× UNL 4.7 Serum Total bilirubin ≤ 1.5× UNL
5. Life expectancy \> 6 months
6. Eligible for concurrent chemoradiotherapy assessed by principle investigator;
7. No obvious active bleeding;
8. Written informed consent must be available before study registration.

Exclusion Criteria:

1. Recurrent or distant metastatic disease;
2. Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;
3. Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;
4. Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study;
5. Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;
6. Previous organ transplantation or HIV patients;
7. Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component;
8. Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA\> 103 copies/ml.

Where it's running

• RenJi hospital
  Shanghai, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.