Phase II study: a study to explore the safety and preliminary efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab Phase III study: a confirmatory study to evaluate the safety and efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab as first-line therapy for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer
Female patients, aged ≥18 years to ≤70 years, who voluntarily sign the informed consent form;
With persistent, recurrent or metastatic (the Federation International of Gynecology and Obstetrics [FIGO] Stage IVB) cervical cancer confirmed histologically (pathological reports required), including pathological types of squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma and clear-cell renal-cell carcinoma, not amenable to radical surgery and/or radical radiotherapy or radiochemotherapy, with no prior systemic anti-tumor therapy for persistent, recurrent or metastatic cervical cancer;
Subjects should be positive for PD-L1 expression (CPS ≥ 1) in tumor specimens by the central laboratory. Subjects should provide sufficient formalin-fixed paraffin-embedded (FFPE) specimens or sections (6 sections recommended, not less than 3 sections), and be willing to undergo a tumor tissue biopsy for PD-L1 testing when necessary. The archival tissues must be representative tumor specimens collected within three years or unstained continuous sections of FFPE tumor tissues freshly resected within six months, and relevant pathological reports of the aforementioned specimens must also be provided. Both surgical resection and biopsy are acceptable methods for acquiring fresh tissue specimens; fine-needle aspiration and liquid-based cytology (TCT) samples (i.e., samples lacking complete tissue structures and providing only cell suspension and/or cell smears) are not acceptable; decalcified bone metastasis tumor tissue specimens are not acceptable;
At least one measurable tumor lesion per RECIST v1.1; lesions at sites previously treated with radiotherapy or other loco-regional therapies can only be considered as non-target lesions, unless unequivocal progression of the lesion occurs or the tumor activity of the lesion is confirmed by biopsy and the lesion is measurable
Subjects with other pathological types of cervical cancer, such as small cell carcinoma, sarcoma, etc.;
Pregnant or lactating women;
Prior radiotherapy within 14 days before the first dose. Except for palliative area radiotherapy for bone metastases for which pain cannot be effectively controlled by systemic therapy or local pain relief (radiotherapy area < 5% of bone marrow area); prior chemotherapeutic agents for increasing the sensitization to radiotherapy within 14 days before the first dose; prior use of traditional Chinese patent medicines or treatment with anti-tumor related functions as specified in the NMPA-approved package inserts within 14 days before the first dose, or Chinese herbal medicines for anti-tumor purposes clearly documented in the medical record ;
Patients who received live/attenuated vaccines and mRNA vaccines within 4 weeks prior to screening or scheduled to receive those vaccines during the study period;
Parallel
Recombinant humanized anti-PD-1 monoclonal antibody injection
DrugStrength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W).
Cisplatin
Drugthe usage and dosage should be determined by the investigator
Bevacizumab Injection
DrugStrength 100 mg/4 mL, recommended dose 15 mg/kg body weight, administered every 3 weeks (15 mg/kg, Q3W)
carboplatin
Drugthe usage and dosage should be determined by the investigator
Paclitaxel for Injection
Drugthe usage and dosage should be determined by the investigator
Progression-Free Survival (PFS)
Tumor assessment is performed according to RECIST 1.1. Tumor imaging assessment is performed every 9 weeks (±7 days) after the first administration until week 54. After that, it is performed once every 12 weeks (±7 days) until disease progression, withdrawal from the group, loss to follow-up, death, or 24 months after the first study drug administration at the longest distance, whichever occurs first.
Overall Survival
Tumor assessment is performed according to RECIST 1.1. Tumor imaging assessment is performed every 9 weeks (±7 days) after the first administration until week 54. After that, it is performed once every 12 weeks (±7 days) until disease progression, withdrawal from the group, loss to follow-up, death, or 24 months after the first study drug administration at the longest distance, whichever occurs first.
Vital signs
Number of cases with abnormal vital signs results
Physical examination
Number of cases with abnormal physical examination results
Laboratory Examination
Number of cases with abnormal laboratory examination results
Adverse event
Number of cases with all adverse medical events that occur after the subject receives the investigational drug assessed by CTCAE V5.0
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