Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in 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: Neoadjuvant Therapy, CCRT, Brachytherapy.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: from 18 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
A Prospective Randomized Controlled Trials of Neoadjuvant Chemotherapy Combined With Serplulimab Followed by Concurrent Chemoradiation Versus Concurrent Chemoradiation Therapy Alone in Advanced Cervical Cancer
Overview
The main objective of this study is to determine whether neoadjuvant chemotherapy combined with slulimumab sequential concurrent chemoradiotherapy versus concurrent chemoradiotherapy for locally advanced cervical cancer could improve progression-free survival rates. Women in the experimental arm will receive neoadjuvant chemotherapy (cisplatin plus paclitaxel) combined with slulimumab every 21 days during 2 cycles followed by concurrent chemoradiation therapy. Women in the control arm will receive concurrent chemoradiation therapy alone. 286 patients will be recruited during 2 years, with 3 years of follow up period.
Interventions
- Drug Neoadjuvant Therapy
Cisplatin 50 mg/m\^2 d1 q21+ Paclitaxel 175 mg/m\^2 d1 q21+serplulimab 300mg d1 q21 - Radiation CCRT
weekly cisplatin for 4 or 5 weeks is administered concomitant with EBRT (45-50.4Gy) in 1.8-2 daily fractions and a 10-20 Gy boost to reach a total dose of 65 Gy when there was unresectable lymph nodes. - Radiation Brachytherapy
The primary cervical tumor is the boosted, using image guided 3D brachytherapy or 2D brachytherapy, with an additional 30-40 Gy to HRCTV (3D brachytherapy) or to point A (2D brachytherapy), to achieve a total dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors.
Primary outcome measures
- Progression free survival (PFS) [Time frame: Up to approximately 36 months]
Secondary outcome measures (3)
- Overall Survival (OS) [Time frame: Up to approximately 48 months]
- Objective Response Rate (ORR) [Time frame: Up to approximately 36 months]
- Number of Participants Who Experience One or More Adverse Events (AEs) [Time frame: Up to approximately 36 months]
Eligibility criteria
Inclusion criteria
- Age ≥18 years old
- Patients must have histologically confirmed cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 Ib3-IIIc2.
- According to the RECIST 1.1 standard, the subject must have at least one measurable target lesion
- No prior treatment
- Expected survival period ≥ 3 months
- ECOG score: 0-1
- No obvious signs of hematological diseases, ANC≥1.5×10\^9/L, platelet count≥100×10\^9/L, Hb≥90g/L, WBC≥3.0×10\^9/L, and no bleeding tendency before enrollment;
- Adequate hepato-renal function is needed, including: Total bilirubin (TBIL)≤1.5×ULN (Gilbert syndrome allows ≤5×ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN Serum creatinine (Cr) ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50mL/min
- Cardiac Function: left ventricular ejection fraction (LVEF) >=50%;
- Patients voluntarily participated in the study and signed informed consent
Exclusion criteria
- Pregnant or breastfeeding female patients (women of child-bearing potential must confirm that the pregnancy test is negative within 7 days before the first administration. If it is positive, ultrasound examination must be performed to exclude pregnancy), or women of child-bearing potential who refused to receive contraceptive measures
- Combined with other malignant tumors, except for cured skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of any other part
- Existence of any bone marrow dysplasia and other abnormal hematopoietic diseases
- Active infections, HIV infections, and viral hepatitis that require systematic treatment
- Patients with≥Grade 1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 5.0
- Had severe cardiovascular diseases such as cerebrovascular accident, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4) and arrhythmia that need drug intervention within 6 months
- It is known to have a history of allergies to research drugs or drug components
- Has clinically significant thyroid dysfunction before enrollment;
- Has participated in other anti-tumor intervention clinical trials within 30 days before the first medication
- Have a clear history of dementia, mental state changes or any mental illness that will hinder understanding or informed consent
- The investigator believes that the patient is not suitable for participating in this clinical research
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sicchuan cancer hospital — Chengdu
Identifiers
NCT: NCT05173272 · KY-2021-109