Clinical trial NCT06093438: Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer
Official title: Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer Patients With High Risk of Recurrence: A Prospective, Single-Arm, Phase II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cervical Cancer
Induction Chemotherapy
Immunotherapy
Keywords: cervical cancer
immunotherapy
neoadjuvant chemotherapy
chemoradiation
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To explore the efficacy of incorporating neoadjuvant immunotherapy into neoadjuvant chemotherapy in locally advanced cervical cancer patients with high risk of recurrence.

Detailed description: For locally advanced cervical cancer patients undergoing definitive chemoradiotherapy, distant metastasis has become a major concern. In this study, investigators selected a subgroup of patients with theoretically higher risk of distant metastasis and intensified their systematic treatment by incorporating PD-L1 inhibitors into neoadjuvant chemotherapy, in order to reduce their risk of distant metastasis and achieve good disease-free survival.

Eligibility criteria: Inclusion Criteria:

1. Untreated locally advanced cervical cancer patients with clear pathological diagnosis
2. 2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameter of their metastatic lymph nodes should ≥1.5cm
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
4. Life expectancy \> 6 months
5. Able to tolerate concurrent chemoradiotherapy assessed by researches
6. No obvious active bleeding;
7. Adequate hematological, renal and hepatic functions:
8. No concomitant malignancies
9. Female subjects of childbearing potential should have a negative pregnancy test and must take effective and reliable contraceptive measures during the clinical trial period;
10. Voluntarily-signed informed consent.

Exclusion Criteria:

1. Concomitant other malignancies;
2. Patients with metastatic or recurrent disease;
3. Patients received any form of treatment before enrollment;
4. Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infections;
5. Impaired hematological, renal or hepatic functions:

   1. Hemoglobin \< 9.0 g/dl
   2. Neutrophils \< 2000 cells/μl; Leukocytes \< 4 × 109/L
   3. Platelets \> 100 × 109/L
   4. Serum ALT/AST \> 2.5×UNL
   5. Serum Total bilirubin \> 1.5× UNL

   g. Serum urea nitrogen (BUN) \> 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) \> 1.5 × upper normal limit (UNL)
6. Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease;
7. Patients with uncontrolled mental diseases;
8. Pregnant or lactating woman;
9. Participating in other clinical trials;
10. Anyone considered not suitable for enrollment by principal investigator;

Primary outcomes:
measure: Overall response rate
timeFrame: 1 year
measure: Volume changes of core radiation targets and irradiated normal tissues after induction treatment
timeFrame: 5-year
Secondary outcomes:
measure: Progression-free survival
timeFrame: 1-year, 2-year
measure: Distant metastasis-free survival
timeFrame: 1-year, 2-year
measure: Incidence of treatment-related side effects
timeFrame: 5-year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Jie Chen
role: PRINCIPAL_INVESTIGATOR
References: