Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Toripalimab.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Induction Chemotherapy, Immunotherapy. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer Patients With High Risk of Recurrence: A Prospective, Single-Arm, Phase II Trial
Overview
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.
Interventions
- Drug Toripalimab
Patients enrolled in this arm would receive three cycles of induction treatment before receiving definitive chemoradiotherapy. The specific regimen is: Paclitaxel(135mg/m2,ivd, d1)+cisplatin(75mg/m2,ivd,d1-3)+Toripalimab (240mg,ivd,d1)±bevacizumab(ivd, d1)/q21d. Patients would receive pelvic MRI to evaluate the regression status of tumor after three cycles of induction treatment. Patients with satisfying tumor regression would receive definitive chemoradiotherapy afterwards. During chemoradiothe
Primary outcome measures
- Overall response rate [Time frame: 1 year]
- Volume changes of core radiation targets and irradiated normal tissues after induction treatment [Time frame: 5-year]
Secondary outcome measures (3)
- Progression-free survival [Time frame: 1-year, 2-year]
- Distant metastasis-free survival [Time frame: 1-year, 2-year]
- Incidence of treatment-related side effects [Time frame: 5-year]
Eligibility criteria
Inclusion criteria
- Untreated locally advanced cervical cancer patients with clear pathological diagnosis
- 2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameter of their metastatic lymph nodes should ≥1.5cm
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Life expectancy > 6 months
- Able to tolerate concurrent chemoradiotherapy assessed by researches
- No obvious active bleeding;
- Adequate hematological, renal and hepatic functions:
- No concomitant malignancies
- Female subjects of childbearing potential should have a negative pregnancy test and must take effective and reliable contraceptive measures during the clinical trial period;
- Voluntarily-signed informed consent.
Exclusion criteria
- Concomitant other malignancies;
- Patients with metastatic or recurrent disease;
- Patients received any form of treatment before enrollment;
- Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infections;
- Impaired hematological, renal or hepatic functions:
- Hemoglobin < 9.0 g/dl
- Neutrophils < 2000 cells/μl; Leukocytes < 4 × 109/L
- Platelets > 100 × 109/L
- Serum ALT/AST > 2.5×UNL
- 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)
- Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease;
- Patients with uncontrolled mental diseases;
- Pregnant or lactating woman;
- Participating in other clinical trials;
- Anyone considered not suitable for enrollment by principal investigator;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Medical University Cancer Institute & Hospital — Tianjin
Identifiers
NCT: NCT06093438 · 2020230207083952035