Overview

Tislelizumab Plus TP as Neoadjuvant Therapy for Local Advanced Cervical Carcinoma

Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
Female
Summary
The goal of this clinical trail is to investigate the efficacy and safety of PD-1 antibody Tislelizumab plus TP regimen (taxane combined with platinum) as neoadjuvant therapy for patients diagnosed as local advanced cervical carcinoma (FIGO staging IB2-IIB).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ruijin Hospital
Treatments:
Carboplatin
Docetaxel
Paclitaxel
Criteria
Inclusion Criteria:

1. Histologically confirmed cervical squamous cell carcinoma.

2. Clinical staging FIGO IB2-IIB, treatment naive.

3. Female patients aged≥18 years.

4. ECOG performance status 0 or 1, expected lifetime≥3 months.

5. Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count
≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥90g/L, ALT/AST ≤2.5x ULN, Serum
bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.

6. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV
DNA<500IU/ml (or 2500 copies/ml).

7. Pregnancy test of female patients with fertile activity should be negative within 7
days before enrollment. Patients should keep contraception during treatment.

8. Willingness and ability to comply with the protocol for the duration of the study
including scheduled visits, examinations, investigations and treatment plans with
informed consent form.

Exclusion Criteria:

1. Pregnancy or children bearing potential.

2. brain or meningeal metastasis.

3. With second primary malignant diseases.

4. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or
patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone).

5. With uncontrollable complications

6. Inadequate organ function

7. Known hypersensitivity reaction to any of the study drugs or components.

9. Other unsuitable conditions determined by investigators.