Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Locally Advanced Cervical Carcinoma; Immunotherapy; Concurrent Chemoradiotherapy

Treatments: Drug: Albumin-Bound Paclitaxel, cisplatin, Sintilimab

Study type: Interventional

Funder types: Other

Identifiers

NCT06391190

ACCI

Details and patient eligibility

About

To explore the safety and efficacy of Albumin-Bound Paclitaxel/Platinum based concurrent chemoradiotherapy Followed by PD-1 inhibitor (Sintilimab) in locally advanced cervical cancer

Full description

Patients with pathologically confirmed locally advanced cervical cancer will be treated with concurrent chemoradiotherapy (weekly Albumin-Bound Paclitaxel and cisplatin), followed by Sintilimab 200mg q3w for 8 cycles.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

treatment arm

Experimental group

Description:

with Albumin-Bound Paclitaxel 50-75mg/m2, cisplatin 25-40 mg/m2 weekly for up to 5 cycles during radical radiation (EBRT followed by brachytherapy); followed by Sintilimab 200mg Q3W for 8 cycles.

Treatment:

Drug: Albumin-Bound Paclitaxel, cisplatin, Sintilimab