Cervical CancerPhase 2/3NCT06123884
BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer
A Phase 2/3 study testing Recombinant humanized anti-PD-1 monoclonal antibody injection, Cisplatin and Bevacizumab Injection in people with Cervical Cancer, run by Bio-Thera Solutions at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Recombinant humanized anti-PD-1 monoclonal antibody injection, Cisplatin and Bevacizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 526 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2023to Jan 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Life expectancy ≥12 weeks as evaluated by the investigator;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score 0 or 1;
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and are willing to take effective birth control/contraceptive methods to prevent pregnancy during the study until 6 months after the last dose of the study drug. Postmenopausal women must have amenorrhea for at least 12 months before they are considered as women of non-childbearing potential.
- 9. Able to understand trial requirements, willing and able to comply with the trial and follow-up procedures.
Who cannot join
- 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;
- Any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) or therapies that target immune co-stimulatory molecules (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40, etc.);
- AEs caused by prior anti-tumor therapy that are still > Grade 1 (as per CTCAE v5.0) before the first dose of the study drug (except for AEs, such as alopecia, fatigue, etc., that cannot be recovered to ≤ Grade 1 and will remain stable for a long time as judged by the investigator based on actual clinical situations, except for Grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy); patients who previously experienced ≥ Grade 3 irAEs or discontinued immunotherapy due to irAEs of any grade;
Show all 19Show fewer
- Active leptomeningeal disease or poorly controlled brain metastases. Patients with suspected or confirmed brain metastases are allowed to be enrolled if they have no obvious symptoms and the results of imaging examinations performed at least 28 days before the first dose of the study drug showed stable disease and no treatment (e.g., radiotherapy, surgery, or corticosteroid treatment) is required to control the symptoms of brain metastases within 28 days before the first dose of the study drug;
- Patients who underwent major organ surgery (excluding aspiration biopsy) or experienced significant trauma within 4 weeks before the first dose of the study drug, or those who require elective surgery during the trial period;
- Subjects with serious infections within 4 weeks before the first dose, including but not limited to the infection-related complications, bacteremia and severe pneumonia requiring hospitalization; subjects with active infection before the first dose are excluded;
- Patients with the following infectious diseases: human immunodeficiency virus (HIV) infection; active hepatitis B virus infection [hepatitis B surface antigen (HBsAg) positive, and the result for hepatitis B virus deoxyribonucleic acid (HBV-DNA) test > 500 IU/ml or 103 copies/ml or above the upper limit of normal at the testing institution]; hepatitis C virus infection [anti-HCV antibodies and hepatitis C virus ribonucleic acid (HCV-RNA) test positive]; Treponema pallidum antibody positive and rapid plasma reagin (RPR) positive;
- Subjects with tuberculosis untreated or under treatment, including but not limited to pulmonary tuberculosis; patients whose tuberculosis was cured after standardized anti-tuberculosis treatment as confirmed by the investigator may be included;
- Subjects with known history of severe allergy or prior ≥ Grade 3 allergic reactions to macromolecular protein preparations/monoclonal antibodies, and any component of the investigational drug;
- Known to have any contraindication to cisplatin/carboplatin or paclitaxel, or allergy to any of their components;
- Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stent insertion as judged by the investigator;
- Subjects with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Patients with active or potentially recurrent autoimmune disease (excluding patients with vitiligo, autoimmune thyroid disorder that can be treated with hormone replacement therapy, or type 1 diabetes mellitus);
- Patients who required systemic treatment with glucocorticoid (>10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days before the first dose of the study drug, except for the following situations: ① topical, ocular, intra-articular, nasal, and inhaled glucocorticoid therapy; ② short-term use of glucocorticoid for prophylaxis (e.g., prevention of contrast allergy);
- Subjects with a history of noninfectious pneumonitis requiring glucocorticoid therapy within 1 year before the first dose or with current interstitial lung disease;
- History of severe cardiovascular and cerebrovascular disorders, including but not limited to: ① New York Heart Association (NYHA) Class II or above cardiac failure or left ventricular ejection fraction (LVEF) <50%; ② Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block, etc.; ③ Acute coronary syndrome, congestive cardiac failure, aortic dissection, stroke, or other Grade 3 or above cardiovascular and cerebrovascular events within 6 months before the first dose; ④ Clinically uncontrollable hypertension (defined in this protocol as systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg despite the use of antihypertensive therapy);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhaohe Wang, Ph.D contact
China1 site, 1 recruiting
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei
Qinglei Gao, Ph.D
About this study
Official title: A Phase II/III 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
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
Read the detailed description
The single-arm Phase II exploratory study designed to evaluate the safety and efficacy of the study drug will include 20-50 subjects to explore the safety and preliminary efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab. Dynamic analysis will be conducted after the inclusion of 20 subject. If the safety of this combination regimen is manageable and the efficacy meets expectations, the enrollment in the Phase II study will be stopped and the Phase III study will be entered. The Phase III study is a randomized, double-blind, multicenter clinical study of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab versus placebo plus platinum-based chemotherapy ± Bevacizumab as first-line therapy for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer. PFS and OS will be used as the combined endpoints, and a superiority design will be adopted with a total sample size of 476 subjects. Stratified block randomization will be performed based on the following random factors: patients will be stratified based on the presence of metastatic diseases at the time of diagnosis (Yes vs. No), PD-L1 CPS (1-10 vs. ≥ 10) and planned use of Bevacizumab (Yes vs. No).
- Conditions
- Cervical Cancer
- Being tested
- Recombinant humanized anti-PD-1 monoclonal antibody injection, Cisplatin, Bevacizumab Injection, carboplatin, Paclitaxel for Injection
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant humanized anti-PD-1 monoclonal antibody injectionDrug
Also called BAT1308 injection
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W).
CisplatinDrug
Also called Shunbo
the usage and dosage should be determined by the investigator
Bevacizumab InjectionDrug
Also called Pobevcy
Strength 100 mg/4 mL, recommended dose 15 mg/kg body weight, administered every 3 weeks (15 mg/kg, Q3W)
carboplatinDrug
Also called Bobei
the usage and dosage should be determined by the investigator
Paclitaxel for InjectionDrug
Also called Tesu
the usage and dosage should be determined by the investigator
| Study group | Role | What they receive |
|---|---|---|
| BAT1308 | Experimental | Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) Receives: Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection; Drug: Cisplatin; Drug: Bevacizumab Injection; Drug: carboplatin; Drug: Paclitaxel for Injection |
| BAT1308 monoclonal antibody | Placebo comparator | Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) Receives: Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection; Drug: Cisplatin; Drug: Bevacizumab Injection; Drug: carboplatin; Drug: Paclitaxel for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first administration to the occurrence of objective tumor progression or all-cause death (whichever occurs first), the assessment period lasts up to two years.
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.
Measured: From the date of first administration to the time of death due to any cause, the assessment period will last up to two years.
Secondary outcomes (7)
Vital signs
Number of cases with abnormal vital signs results
Measured: Through study completion, an average of 2 years
Physical examination
Number of cases with abnormal physical examination results
Measured: Through study completion, an average of 2 years
Laboratory Examination
Number of cases with abnormal laboratory examination results
Measured: Through study completion, an average of 2 years
Adverse event
Number of cases with all adverse medical events that occur after the subject receives the investigational drug assessed by CTCAE V5.0
Measured: Through study completion, an average of 2 years
Objective response rate (ORR)
The proportion of subjects whose tumors have shrunk by a certain amount and remained so for a certain period of time.
Measured: Through study completion, an average of 2 years
anti-drug antibodies
All subjects need to collect blood samples at specific time points during the treatment period. At each time point, about 4.0 mL of blood sample is planned to be collected to detect anti-drug antibodies
Measured: cycle1,cycle3,cycle5 and every 9 weeks after cycle5, 21 days is a cycle and the evaluation lasts for up to 2 years.
neutralizing antibody
All subjects need to collect blood samples at specific time points during the treatment period. At each time point, about 4.0 mL of blood sample is planned to be collected to detect neutralizing antibody
Measured: cycle1,cycle3,cycle5 and every 9 weeks after cycle5, 21 days is a cycle and the evaluation lasts for up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start13 Dec 2023
- Primary completionSep 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 526 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qinglei Gao, Ph.D, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123884
- Sponsor's protocol ID
- BAT-1308-002-CR
- Status last verified
- Feb 2025
- First submitted
- 21 Sep 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III 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
- ClinicalTrials.gov ID
- NCT06123884
- Acronym / sponsor ID
- BAT-1308-002-CR
- Conditions
- Cervical Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The single-arm Phase II exploratory study designed to evaluate the safety and efficacy of the study drug will include 20-50 subjects to explore the safety and preliminary efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab. Dynamic analysis will be conducted after the inclusion of 20 subject. If the safety of this combination regimen is manageable and the efficacy meets expectations, the enrollment in the Phase II study will be stopped and the Phase III study will be entered. The Phase III study is a randomized, double-blind, multicenter clinical study of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab versus placebo plus platinum-based chemotherapy ± Bevacizumab as first-line therapy for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer. PFS and OS will be used as the combined endpoints, and a superiority design will be adopted with a total sample size of 476 subjects. Stratified block randomization will be performed based on the following random factors: patients will be stratified based on the presence of metastatic diseases at the time of diagnosis (Yes vs. No), PD-L1 CPS (1-10 vs. ≥ 10) and planned use of Bevacizumab (Yes vs. No).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAT1308 | Experimental | Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection, Drug: Cisplatin, Drug: Bevacizumab Injection, Drug: carboplatin, Drug: Paclitaxel for InjectionStrength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) |
| BAT1308 monoclonal antibody | Placebo comparator | Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection, Drug: Cisplatin, Drug: Bevacizumab Injection, Drug: carboplatin, Drug: Paclitaxel for InjectionStrength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Life expectancy ≥12 weeks as evaluated by the investigator;
Key exclusion criteria (19 listed)
- 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;
- Any prior treatments targeting the mechanism of tumor immunity, such as immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) or therapies that target immune co-stimulatory molecules (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40, etc.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant humanized anti-PD-1 monoclonal antibody injectionAlso: BAT1308 injectionStrength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W). | Drug | BAT1308, BAT1308 monoclonal antibody |
| CisplatinAlso: Shunbothe usage and dosage should be determined by the investigator | Drug | BAT1308, BAT1308 monoclonal antibody |
| Bevacizumab InjectionAlso: PobevcyStrength 100 mg/4 mL, recommended dose 15 mg/kg body weight, administered every 3 weeks (15 mg/kg, Q3W) | Drug | BAT1308, BAT1308 monoclonal antibody |
| carboplatinAlso: Bobeithe usage and dosage should be determined by the investigator | Drug | BAT1308, BAT1308 monoclonal antibody |
| Paclitaxel for InjectionAlso: Tesuthe usage and dosage should be determined by the investigator | Drug | BAT1308, BAT1308 monoclonal antibody |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From first administration to the occurrence of objective tumor progression or all-cause death (whichever occurs first), the assessment period lasts up to two years.
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
Time frame: From the date of first administration to the time of death due to any cause, the assessment period will last up to two years.
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.
7 secondary outcomes
Vital signs
Time frame: Through study completion, an average of 2 years
Physical examination
Time frame: Through study completion, an average of 2 years
Laboratory Examination
Time frame: Through study completion, an average of 2 years
Adverse event
Time frame: Through study completion, an average of 2 years
Objective response rate (ORR)
Time frame: Through study completion, an average of 2 years
anti-drug antibodies
Time frame: cycle1,cycle3,cycle5 and every 9 weeks after cycle5, 21 days is a cycle and the evaluation lasts for up to 2 years.
neutralizing antibody
Time frame: cycle1,cycle3,cycle5 and every 9 weeks after cycle5, 21 days is a cycle and the evaluation lasts for up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhaohe Wang, Ph.D contact
Qinglei Gao, Ph.D principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Recombinant humanized anti-PD-1 monoclonal antibody injection, Cisplatin and Bevacizumab Injection in people with Cervical Cancer, run by Bio-Thera Solutions at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Chen (18971436492, jchen@bio-thera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From first administration to the occurrence of objective tumor progression or all-cause death (whichever occurs first), the assessment period lasts up to two years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.