Treatment for advanced cervical cancer using chemoradiotherapy and immunotherapy

A Prospective Single Arm Trial of Concurrent Chemoradiotherapy (With Albumin-Bound Paclitaxel/Cisplatin) Followed by PD-1 Inhibitor in Locally Advanced Cervical Cancer

This study is testing a new treatment combining chemotherapy and immunotherapy to see if it helps people with advanced cervical cancer feel better and live longer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: RenJi Hospital (Academic / other)
• Drugs / interventions: prednisone, Sintilimab
• Locations: 1 site (Shanghai)
• Trial ID: NCT06391190 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are untreated adults aged 18 to 75 with pathologically confirmed locally advanced cervical cancer and a good performance status.

Not a fit: Patients with recurrent or metastatic disease or those with prior malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could improve outcomes for patients with advanced cervical cancer.

How similar studies have performed: Other studies have shown promise in using immunotherapy in conjunction with chemoradiotherapy for various cancers, suggesting potential success for this approach in cervical cancer.

Eligibility criteria

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 this trial is running

Shanghai

• RenJi hospital — Shanghai, China (Recruiting)

Conditions Locally Advanced Cervical Carcinoma; Concurrent Chemoradiotherapy; Immunotherapy