Cervical CancerPhase 2NCT05444374
A Phase II Study of Serplulimab Plus Bevacizumab in Combination With Chemotherapy in 1L Treatment of Untreated Recurrent or Metastatic Cervical Cancer
A Phase 2 study testing Serplulimab and Bevacizumab in people with Cervical Cancer, run by Sichuan Cancer Hospital and Research Institute at 4 sites in China.
Trial summary
This study is a single-arm, multicenter, Phase II study to evaluate the efficacy and safety of the treatment of Serplulimab plus Bevacizumab in combination with chemotherapy in 1L treatment of patients with untreated recurrent or metastatic cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Serplulimab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesChina
- Study dates
- 1 Oct 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form (ICF)
- Women, age ≥ 18 years and ≤ 75 years at time of signing ICF
- Histologically or cytologically confirmed cervical cancer (pathological types: squamous cell carcinoma, adenocarcinoma [except mucinous adenocarcinoma], adenosquamous carcinoma)
- Recurrent, progressive, or metastatic cervical cancer that is not amenable to surgery or radiotherapy/chemoradiotherapy (other than palliative radiotherapy to bone lesions). Recurrent and metastatic lesions should provide cytological and/or pathological biopsy evidence of cervical cancer metastasis as far as possible.
- No systemic anti-tumor treatment for this recurrent, progressive or metastatic tumor. Note: a. Patients with initially diagnosed stage IVb disease should not have received systemic anti-tumor treatment; b. For patients previously treated with platinum-based first-line (neoadjuvant) adjuvant chemotherapy/radical chemoradiotherapy, the time from the last chemotherapy to disease recurrence is > 6 months; c. Patients treated with radiotherapy/concurrent chemoradiotherapy (only receiving platinum-based sensitization) can be enrolled after the completion of radiotherapy if they relapse outside the radiation field. If there is recurrence within the radiation field (RECIST 1.1 is met) and the target lesion is located in the radiation field, the patient can be enrolled more than 3 months after the completion of radiotherapy; d. For patients who have not received previous chemoradiotherapy, if chemoradiotherapy is required first (only platinum single agent sensitization is received), the patient can be enrolled more than 3 weeks after the completion of radiotherapy.
- Prior anticancer TCM therapy must have ended ≥ 7 days prior to first study treatment (Cycle 1, Day 1) and all antineoplastic treatment-related AEs must have recovered to ≤ Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 5.0 (except Grade 2 alopecia).
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- At least one measurable target lesion as assessed by the investigator per RECIST 1.1 within 4 weeks prior to enrollment.
- Note: Measurable target lesions should not have received local therapy such as radiotherapy (for lesions located in previously irradiated areas, target lesions can also be selected in case of definite progression [according to RECIST 1.1]).
- ECOG PS score of 0 or 1 within 7 days prior to enrollment.
- Expected survival ≥ 12 weeks.
- Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-). Hepatitis B virus deoxyribonucleic acid (HBV-DNA) < 2500 copies/mL or 500 IU/mL if HBsAg (+) or HBcAb (+).
- Subjects who are HCV antibody (-) or HCV-RNA negative may be enrolled; if HCV-RNA is positive, subjects must have alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 × ULN to be enrolled. Subjects with co-infection with hepatitis B and C are excluded (positive test for HBsAg or HBcAb and positive test for HCV antibody).
- Adequate major organ function as defined by the following criteria (no transfusions, albumin, recombinant human thrombopoietin, or colony-stimulating factor [CSF] within 14 days prior to enrollment in this study):
- Hematological system Neutrophils (ANC) 1.5 x 109/L Platelets (PLT) 100 x 109/L Hemoglobin (Hb) 90 g/L Hepatic function Total bilirubin (TB) ≤ 1.5 x upper limit of normal (ULN) Alanine aminotransferase (ALT) ≤ 2.5 × ULN;
- 5 × ULN for patients with liver metastases; Aspartate aminotransferase (AST) ≤ 2.5 × ULN;
- 5 × ULN for patients with liver metastases; Albumin ≥ 30 g/L Renal function Serum creatinine (Cr) ≤ 1.5 × ULN; Creatinine clearance ≥ 60 mL/min if > 1.5 × ULN (calculated according to Cockcroft-Gault formula) Coagulation function Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN 13. Female patients must meet: i. Menopause (defined as no menses for at least 1 year and no other confirmed cause other than menopause), or ii. Have been surgically sterilized (removal of ovaries and/or uterus), or iii. Childbearing potential, but must meet:
- Must have a negative serum pregnancy test within 7 days prior to randomization, and
- Agree to practice contraception with an annual failure rate of < 1% or remain abstinent (refrain from heterosexual intercourse) (from signing the ICF to at least 6 months after the last dose of investigational drug and at least 6 months after the last dose of chemotherapeutic drugs) (methods of contraception with an annual failure rate of < 1% include bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper-containing intrauterine devices or condoms), AND
- Do not breastfeed.
Who cannot join
- Patients who meet any of the following exclusion criteria will not be enrolled in the study:
- Other active malignancy within 2 years or concurrently. Cured localized tumors, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer and breast carcinoma in situ, can be enrolled.
- Patients who are scheduled for or have received prior organ or bone marrow transplantation.
- Patients with uncontrolled pleural effusion, pericardial effusion or ascites.
- Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging studies or pathology.
- Myocardial infarction within 6 months prior to enrollment, poorly controlled arrhythmia (including QTc interval ≥ 470 ms for females) (QTc interval calculated using Fridericia's formula).
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- Class III-IV cardiac dysfunction according to New York Heart Association (NYHA) criteria or echocardiography: left ventricular ejection fraction (LVEF) < 50%.
- Poorly controlled hypertension (defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg), previous hypertensive crisis or hypertensive encephalopathy.
- Human immunodeficiency virus (HIV) infection.
- Patients with active pulmonary tuberculosis.
- Patients with previous and current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, severely impaired pulmonary function, etc., which may interfere with the detection and management of suspected drug-related pulmonary toxicity.
- Patient has known active or suspected autoimmune disease. Patients with immune-related hypothyroidism on thyroid hormone replacement therapy and patients with well-controlled type I diabetes are allowed. Recovered Vitiligo or childhood asthma/allergies that do not require intervention or that do not require any intervention in adulthood are allowed.
- Treatment with a live vaccine within 28 days prior to enrollment. However, inactivated viral vaccines for seasonal influenza are allowed, but live attenuated influenza vaccines for intranasal use are not allowed.
- Patients requiring systemic corticosteroids (> 10 mg/day prednisone efficacy dose) or other immunosuppressive medications within 14 days prior to enrollment or during the study. However, patients were permitted to use topical or inhaled corticosteroids and adrenal glucocorticoid replacement at doses ≤ 10 mg/day prednisone for efficacy in the absence of active autoimmune disease.
- Any active infection requiring systemic anti-infective therapy within 14 days prior to enrollment.
- Major surgery within 28 days prior to enrollment, this study Major surgery is defined as surgery that requires at least 3 weeks of recovery from surgery to be able to receive treatment for this study. Patients with tumor aspirate or lymph node harvest biopsy were allowed to enroll.
- The patient has previously received other antibodies/drugs against immune checkpoints, such as PD-1, PD-L1, cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and other treatments.
- Ongoing participation in another clinical study, or planned initiation of treatment in this study less than 14 days from the end of treatment in the previous clinical study.
- Presence of free air in the abdomen that cannot be explained by puncture or recent surgical procedure.
- Presence of bladder or rectal fistula at screening.
- Acute intestinal obstruction or incomplete obstruction within 6 months. However, patients with complete response (CR) after surgical treatment may be enrolled.
- Uncontrolled tumor-related pain.
- Known history of serious allergy to any monoclonal antibody.
- Known hypersensitivity to any of the cisplatin or paclitaxel components.
- Pregnant or lactating women.
- Patient has a known history of psychiatric drug abuse or drug abuse; patient has a history of alcohol abuse.
- The patient has other factors that, in the judgment of the investigator, may lead to forced early termination of the study.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Hunan Cancer Hospital
Changsha, Hunan
Ranran Wang, 0731-89762695, hnszlyy_irb@163.com
Jie Tang
Sicchuan Cancer Hospital
Chengdu, Sichuan, 610000
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Guangyi Sui, 0451-86298295, hydsyll@163.com
Ge Lou
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Yuanyuan Zhu, 027-85726375, whunionlunli@126.com
Guiling Li
About this study
Official title: A Single-Arm, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of Serplulimab Plus Bevacizumab in Combination With Chemotherapy in 1L Treatment of Patients With Untreated Recurrent or Metastatic Cervical Cancer
This study is a single-arm, multicenter, Phase II study to evaluate the efficacy and safety of the treatment of Serplulimab plus Bevacizumab in combination with chemotherapy in 1L treatment of patients with untreated recurrent or metastatic cervical cancer.
Approximately 48 eligible subjects are planned to be enrolled across all sites.
Read more
The dosing regimen is: Serplulimab plus Bevacizumab combined with chemotherapy (cisplatin, paclitaxel).
Each cycle is 21 days (every 3 weeks). Subjects will receive Cisplatin plus Paclitaxel up to 4-6 cycles. The maximum duration of treatment with Serplulimab is 2 years (up to 35 cycles).
During the study treatment period, the subjects will receive imaging examination and response assessments every 6 weeks (± 7 days) in the first 48 weeks, every 9 weeks (± 7 days) in 48-96 weeks, and then every 12 weeks (± 7 days). After the treatment discontinuation visit, the subjects will enter the safety follow-up period and survival follow-up period.
- Conditions
- Cervical Cancer
- Being tested
- Serplulimab, Bevacizumab
- 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.
SerplulimabDrug
Recombinant anti-PD-1 humanized monoclonal antibody injection
BevacizumabDrug
Humanized anti-VEGF monoclonal antibody injection
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab plus Bevacizumab Combined With Chemotherapy | Experimental | Each cycle being 21 days, Cisplatin plus Paclitaxel up to 4-6 cycles, the maximum duration of treatment with Serplulimab is 2 years (up to 35 cycles).
* Serplulimab, 300 mg IV, Day1 of each cycle
* Bevacizumab, 7.5 mg/kg, IV, Day1 of each cycle
* Cisplatin: 50 mg/m2, IV, Day1 of each cycle
* Paclitaxel: 175 mg/m2, IV, Day1 of each cycle Receives: Drug: Serplulimab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Defined as the proportion of patients whose best overall response is a partial response (PR) or a CR during the study, as determined by investigators
Measured: Up to approximately 2 years
Secondary outcomes (5)
Progression Free Survival (PFS)
Defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by investigators
Measured: Up to approximately 2 years
Duration of Response (DOR)
Defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression, or death from any cause, whichever occurs first
Measured: Up to approximately 2 years
Disease Control Rate (DCR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD)
Measured: Up to approximately 2 years
3-year Overall Survival (OS)
Defined as the time from enrollment to death, regardless of cause of death. For subjects who had not been reported to have died at the time of analysis, the date they were last known to be alive was used as the censoring date for OS
Measured: Up to approximately 2 years
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Measured: From randomization through 30 days after last dose of study treatment (Up to approximately 25 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Oct 2022 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guonan Zhang, Sichuan Cancer Hospital and Research Institute
- Investigators
- Guonan Zhang, Principal investigator, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444374
- Sponsor's protocol ID
- HLX10IIT05
- Status last verified
- Jun 2022
- First submitted
- 29 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waggoner SE. Cervical cancer. Lancet. 2003 Jun 28;361(9376):2217-25. doi: 10.1016/S0140-6736(03)13778-6.
PubMed 12842378Pfaendler KS, Tewari KS. Changing paradigms in the systemic treatment of advanced cervical cancer. Am J Obstet Gynecol. 2016 Jan;214(1):22-30. doi: 10.1016/j.ajog.2015.07.022. Epub 2015 Jul 26.
PubMed 26212178Todo Y, Watari H. Concurrent chemoradiotherapy for cervical cancer: background including evidence-based data, pitfalls of the data, limitation of treatment in certain groups. Chin J Cancer Res. 2016 Apr;28(2):221-7. doi: 10.21147/j.issn.1000-9604.2016.02.10.
PubMed 27199520Verma J, Monk BJ, Wolfson AH. New Strategies for Multimodality Therapy in Treating Locally Advanced Cervix Cancer. Semin Radiat Oncol. 2016 Oct;26(4):344-8. doi: 10.1016/j.semradonc.2016.05.003. Epub 2016 May 26.
PubMed 27619255Moore DH, Blessing JA, McQuellon RP, Thaler HT, Cella D, Benda J, Miller DS, Olt G, King S, Boggess JF, Rocereto TF. Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol. 2004 Aug 1;22(15):3113-9. doi: 10.1200/JCO.2004.04.170.
PubMed 15284262Liu H, Wang D, Tang J, Wang C, Li X, Lou G, Zhang G. Serplulimab combined with bevacizumab and chemotherapy as first-line treatment for recurrent or metastatic cervical cancer (ASTRUM-CC01): a phase II trial. Front Immunol. 2026 Aug 18;17:1923961. doi: 10.3389/fimmu.2026.1923961. eCollection 2026.
PubMed 42682706
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of Serplulimab Plus Bevacizumab in Combination With Chemotherapy in 1L Treatment of Patients With Untreated Recurrent or Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT05444374
- Acronym / sponsor ID
- HLX10IIT05
- Conditions
- Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jul 2022 (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.
This study is a single-arm, multicenter, Phase II study to evaluate the efficacy and safety of the treatment of Serplulimab plus Bevacizumab in combination with chemotherapy in 1L treatment of patients with untreated recurrent or metastatic cervical cancer.
Approximately 48 eligible subjects are planned to be enrolled across all sites.
The dosing regimen is: Serplulimab plus Bevacizumab combined with chemotherapy (cisplatin, paclitaxel).
Each cycle is 21 days (every 3 weeks). Subjects will receive Cisplatin plus Paclitaxel up to 4-6 cycles. The maximum duration of treatment with Serplulimab is 2 years (up to 35 cycles).
During the study treatment period, the subjects will receive imaging examination and response assessments every 6 weeks (± 7 days) in the first 48 weeks, every 9 weeks (± 7 days) in 48-96 weeks, and then every 12 weeks (± 7 days). After the treatment discontinuation visit, the subjects will enter the safety follow-up period and survival follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab plus Bevacizumab Combined With Chemotherapy | Experimental | Drug: Serplulimab, Drug: BevacizumabEach cycle being 21 days, Cisplatin plus Paclitaxel up to 4-6 cycles, the maximum duration of treatment with Serplulimab is 2 years (up to 35 cycles). * Serplulimab, 300 mg IV, Day1 of each cycle * Bevacizumab, 7.5 mg/kg, IV, Day1 of each cycle * Cisplatin: 50 mg/m2, IV, Day1 of each cycle * Paclitaxel: 175 mg/m2, IV, Day1 of each cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signed Informed Consent Form (ICF)
- Women, age ≥ 18 years and ≤ 75 years at time of signing ICF
- Histologically or cytologically confirmed cervical cancer (pathological types: squamous cell carcinoma, adenocarcinoma [except mucinous adenocarcinoma], adenosquamous carcinoma)
- Recurrent, progressive, or metastatic cervical cancer that is not amenable to surgery or radiotherapy/chemoradiotherapy (other than palliative radiotherapy to bone lesions). Recurrent and metastatic lesions should provide cytological and/or pathological biopsy evidence of cervical cancer metastasis as far as possible.
- No systemic anti-tumor treatment for this recurrent, progressive or metastatic tumor. Note: a. Patients with initially diagnosed stage IVb disease should not have received systemic anti-tumor treatment; b. For patients previously treated with platinum-based first-line (neoadjuvant) adjuvant chemotherapy/radical chemoradiotherapy, the time from the last chemotherapy to disease recurrence is > 6 months; c. Patients treated with radiotherapy/concurrent chemoradiotherapy (only receiving platinum-based sensitization) can be enrolled after the completion of radiotherapy if they relapse outside the radiation field. If there is recurrence within the radiation field (RECIST 1.1 is met) and the target lesion is located in the radiation field, the patient can be enrolled more than 3 months after the completion of radiotherapy; d. For patients who have not received previous chemoradiotherapy, if chemoradiotherapy is required first (only platinum single agent sensitization is received), the patient can be enrolled more than 3 weeks after the completion of radiotherapy.
Key exclusion criteria (27 listed)
- Patients who meet any of the following exclusion criteria will not be enrolled in the study:
- Other active malignancy within 2 years or concurrently. Cured localized tumors, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer and breast carcinoma in situ, can be enrolled.
- Patients who are scheduled for or have received prior organ or bone marrow transplantation.
- Patients with uncontrolled pleural effusion, pericardial effusion or ascites.
- Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging studies or pathology.
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 |
|---|---|---|
| SerplulimabRecombinant anti-PD-1 humanized monoclonal antibody injection | Drug | Serplulimab plus Bevacizumab Combined With Chemotherapy |
| BevacizumabHumanized anti-VEGF monoclonal antibody injection | Drug | Serplulimab plus Bevacizumab Combined With Chemotherapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Defined as the proportion of patients whose best overall response is a partial response (PR) or a CR during the study, as determined by investigators
5 secondary outcomes
Progression Free Survival (PFS)
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
3-year Overall Survival (OS)
Time frame: Up to approximately 2 years
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: From randomization through 30 days after last dose of study treatment (Up to approximately 25 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Background: PubMed 12842378Waggoner SE. Cervical cancer. Lancet. 2003 Jun 28;361(9376):2217-25. doi: 10.1016/S0140-6736(03)13778-6.
- Background: PubMed 26212178Pfaendler KS, Tewari KS. Changing paradigms in the systemic treatment of advanced cervical cancer. Am J Obstet Gynecol. 2016 Jan;214(1):22-30. doi: 10.1016/j.ajog.2015.07.022. Epub 2015 Jul 26.
- Background: PubMed 27199520Todo Y, Watari H. Concurrent chemoradiotherapy for cervical cancer: background including evidence-based data, pitfalls of the data, limitation of treatment in certain groups. Chin J Cancer Res. 2016 Apr;28(2):221-7. doi: 10.21147/j.issn.1000-9604.2016.02.10.
- Background: PubMed 27619255Verma J, Monk BJ, Wolfson AH. New Strategies for Multimodality Therapy in Treating Locally Advanced Cervix Cancer. Semin Radiat Oncol. 2016 Oct;26(4):344-8. doi: 10.1016/j.semradonc.2016.05.003. Epub 2016 May 26.
- Background: PubMed 15284262Moore DH, Blessing JA, McQuellon RP, Thaler HT, Cella D, Benda J, Miller DS, Olt G, King S, Boggess JF, Rocereto TF. Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol. 2004 Aug 1;22(15):3113-9. doi: 10.1200/JCO.2004.04.170.
- Derived from this study: PubMed 42682706Liu H, Wang D, Tang J, Wang C, Li X, Lou G, Zhang G. Serplulimab combined with bevacizumab and chemotherapy as first-line treatment for recurrent or metastatic cervical cancer (ASTRUM-CC01): a phase II trial. Front Immunol. 2026 Aug 18;17:1923961. doi: 10.3389/fimmu.2026.1923961. eCollection 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Guonan Zhang principal investigator
Sichuan Cancer Hospital and Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab and Bevacizumab in people with Cervical Cancer, run by Sichuan Cancer Hospital and Research Institute at 4 sites 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 19 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guonan Zhang (86-13881866599, zhanggn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05444374, which also lists 6 linked publications.
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 5 Jul 2022.