Clinical trial NCT05173272: Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in Advanced Cervical Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cervical Cancer
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 286
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: Up to approximately 36 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 48 months
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 36 months
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 36 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sicchuan cancer hospital
state: Sichuan
Study officials:
affiliation: Sichuan Cancer Hospital and Research Institute
name: Guonan Zhang
role: PRINCIPAL_INVESTIGATOR
References: