Clinical trial NCT05013268: Tislelizumab Plus TP as Neoadjuvant Therapy for Local Advanced Cervical Carcinoma
Official title: The Efficacy and Safety of Tislelizumab Combined With Taxanes and Platinum as Neoadjuvant Therapy for Patients With Local Advanced Cervical Carcinoma， an Open Lable，Single-center, Exploratory Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cervical Squamous Cell Carcinoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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).

Detailed description: This phase I study is being conducted to establish efficacy and safety of Tislelizumab plus TP regimen (taxane combined with platinum) as neoadjuvant therapy for patients diagnosed as local advanced cervical carcinoma (FIGO staging IB2-IIB).

All enrolled patients will receive same intervention. Treatment naïve patients who are diagnosed as local advanced cervical squamous cell carcinoma will receive Tislelizumab plus TP regimen before surgery for 3 cycles. After treatment, radiographic evaluation will be performed to assess clinical efficacy. Patients who have objective response will undergo radical surgery. Patients who are disease stable or progression will undergo radical chemoradiotherapy. The primary endpoint is major pathological response rate (MPR).

Eligibility 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.

Primary outcomes:
measure: Major pathological response (MPR) rate
timeFrame: Up to approximately 8 weeks following completion of neoadjuvant treatment
Secondary outcomes:
measure: Pathological Complete Response (pCR) Rate
timeFrame: Up to approximately 8 weeks following completion of neoadjuvant treatment
measure: Objective response rate (ORR)
timeFrame: Up to 30 days after last completion of neoadjuvant treatment
measure: Relapse free survival (RFS)
timeFrame: Up to approximately 36 months
measure: Disease free survival (DFS)
timeFrame: Up to approximately 36 months
measure: Adverse Events
timeFrame: Up to approximately 12 months
measure: Overall survival (OS)
timeFrame: Up to approximately 60 months
Other outcomes:
measure: Biomarkers analysis
timeFrame: Up to approximately 12 months
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Study officials:
affiliation: Ruijin Hospital
name: Yan Shi
role: PRINCIPAL_INVESTIGATOR
References: