Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in Advanced Cervical Cancer
NCT ID: NCT05173272
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
286 participants
INTERVENTIONAL
2023-07-24
2028-12-28
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental: Neoadjuvant Therapy+CCRT
Patients will be treated with 2 cycles of neoadjuvant chemotherapy (Cisplatin 50 mg/m\^2 d1 q21+ Paclitaxel 175 mg/m\^2 d1 q21) combined with serplulimab （300mg d1 q21）. After that, weekly cisplatin 30mg/m\^2 for 4 or 5 weeks is administered concomitant with external beam radiotherapy (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. 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. All radiotherapy should be completed within eight weeks.
Neoadjuvant Therapy
Cisplatin 50 mg/m\^2 d1 q21+ Paclitaxel 175 mg/m\^2 d1 q21+serplulimab 300mg d1 q21
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.
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.
Experimental: CCRT alone
weekly cisplatin 40mg/m\^2 for 4 or 5 weeks is administered concomitant with external beam radiotherapy (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. 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. All radiotherapy should be completed within eight weeks.
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.
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.
Interventions
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Neoadjuvant Therapy
Cisplatin 50 mg/m\^2 d1 q21+ Paclitaxel 175 mg/m\^2 d1 q21+serplulimab 300mg d1 q21
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Sichuan Cancer Hospital and Research Institute
OTHER
Responsible Party
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Guonan Zhang
Director, Head of Gynecologic Oncology Center, Clinical Professor
Principal Investigators
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Guonan Zhang
Role: PRINCIPAL_INVESTIGATOR
Sichuan Cancer Hospital and Research Institute
Locations
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Sicchuan cancer hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Guonan Zhang
Role: primary
Hong Liu
Role: backup
Other Identifiers
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KY-2021-109
Identifier Type: -
Identifier Source: org_study_id