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New treatment option for Cervical Cancer
Official title Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer
ClinicalTrials.gov ID: NCT06093438
What this study is testing
What is Toripalimab?
Toripalimab is an investigational medicine, given as an once-weekly, being studied as a potential treatment for cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To explore the efficacy of incorporating neoadjuvant immunotherapy into neoadjuvant chemotherapy in locally advanced cervical cancer patients with high risk of recurrence.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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 people 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.
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.