Stage IVB Cervical CancerPhase 2NCT04974944
First-line Treatment With Camrelizumab + Apatinib Versus Chemotherapy + Bevacizumab in Advanced Cervical Cancer
A Phase 2 study testing Camrelizumab, Apatinib and Paclitaxel in people with Stage IVB Cervical Cancer and Recurrent Cervical Cancer, run by Sun Yat-Sen University Cancer Center at 1 site in China.
Trial summary
Cervical cancer is the second-most common cancer in the world and is a leading cause of cancer death among women in developing countries. Cisplatin-based chemotherapy +/- bevacizumab have been recommended as the first-line treatment for patients who present with metastatic (e.g. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Stage IVB Cervical Cancer, Recurrent Cervical Cancer, Persistent Cervical Cancer
- What is being tested?
- Camrelizumab, Apatinib and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2021to 8 Jan 2024
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form (ICF)
- Age ≥ 18 years and ≤ 70 years
- Patients must have primary stage IVB, recurrent or persistent squamous cell carcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment with surgery and/or radiation therapy NOTE: Prior adjuvant therapy is NOT counted as a systemic chemotherapeutic regimen for management of recurrent, persistent or metastatic carcinoma of the cervix; adjuvant therapy includes cisplatin given concurrent with primary radiation therapy (CCRT) and adjuvant chemotherapy given following the completion of concurrent chemotherapy and radiation therapy
- Patients must have measurable disease per RECIST v1.1; measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded as ≥ 10 mm with computed tomography (CT) scan, magnetic resonance imaging (MRI); a lymph node must be ≥ 15 mm in short axis. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
- Life expectancy exceeds 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Has the ability to swallow pills
- Provide cervical cancer tissue (archival or fresh biopsy specimen) prior to randomization for PD-L1 immunohistochemistry (IHC) testing by central laboratory
- Has PD-L1 IHC CPS ≥ 1 by central laboratory testing
- Has adequate organ function
- Female participants must not be pregnant, not breastfeeding. Female participants of childbearing potential should be willing to use one acceptable contraception (i.e., oral contraceptives, contraceptive injections, contraceptive implants, spermicides, condoms, intrauterine devices [IUDs]) during the treatment period and for 180 days following the end
Who cannot join
- Has an active autoimmune disease that has required systemic treatment; replacement therapy is not considered a form of systemic treatment.
- Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Has pleural effusion and ascites that require punctured and drained. However, an exception includes patients with pleural effusion and ascites who have no symptoms.
- Has bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. Ureteral stent placement must be performed in patients with unilateral hydronephrosis prior to enrollment.
- Patients with a prior invasive malignancy who have had any evidence of disease within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
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- Clinically significant cardiovascular diseases, including but not limited to congestive heart failure (New York heart association (NYHA) class > 2), unstable or severe angina, severe acute myocardial infarction, or cardiac arrhythmia requiring medical intervention within 6 months before enrollment.
- Prior or concurrent diagnosis of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, and active pneumonia detected by CT during the screening period.
- Hypertension that can not be well controlled through antihypertensive drugs (systolic pressure ≥ 140 mm Hg and/or diastolic pressure ≥ 90 mm Hg)
- Proteinuria ≥ (++) or 24 hours total urine protein > 1.0 g.
- Patients have coagulation abnormalities with a tendency to bleed or are receiving thrombolytic or anticoagulant therapy. Prophylactic use of aspirin (≤100mg/d), low-molecular-weight-heparin (≤40mg/d), and Rivaroxaban is permitted.
- Any hemorrhage or bleeding event ≥ CTCAE Grade 2 within 4 weeks prior to the first dose of study intervention;
- Arterial thrombus or phlebothrombosis within 6 months prior to randomization.
- Gastrointestinal fistula, bladder/ureteral fistula, or intestinal obstruction within 6 months prior to randomization
- Has radiation-induced enteritis within 12 months prior to randomization
- Has received anticancer treatment, including but not limited to radiotherapy, chemotherapy, and surgery within 4 weeks before the first dose of study intervention
- Any unresolved toxicities (i.e., ≤ Grade 1 or at baseline) from prior therapy, with exception of alopecia;
- Has an active infection requiring systemic therapy or baseline white blood cells >1.5 × 10 9 / L;
- Has known active hepatitis B disease (hepatitis B virus [HBV] DNA > 500 IU/ml 1000 copies/ml) or hepatitis C disease;
- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, apatinib, and bevacizumab.
- Has a known history of human immunodeficiency virus (HIV) infection;
- Pregnant or breastfeeding.
- According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Phase 2 Randomized Trial of Camrelizumab (SHR1210) Plus Apatinib Versus Paclitaxel and Cisplatin/Carboplatin Plus Bevacizumab as a First-line Therapy in Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
Cervical cancer is the second-most common cancer in the world and is a leading cause of cancer death among women in developing countries. Cisplatin-based chemotherapy +/- bevacizumab have been recommended as the first-line treatment for patients who present with metastatic (e.g. stage IVB), persistent, or recurrent cervical cancer. However, patients in this setting are rarely curable. The immune checkpoint inhibitor (ICI) therapy, including cytotoxic T-lymphocyte antigen 4 (CTLA-4), programmed death-1 (PD-1), and programmed death-ligand 1 (PD-L1) inhibitors, has revolutionized the treatment of several cancers. The investigator previously reported the promising antitumor efficacy of camrelizumab (PD-1 inhibitor) combined with apatinib (VEGFR2 inhibitor) as second-line, or later, therapy in patients with advanced cervical cancer. This randomized study is to assess the efficacy and safety of first-line treatment with camrelizumab plus apatinib compared to the efficacy and safety of paclitaxel and cisplatin/carboplatin plus bevacizumab in patients with stage IVB, recurrent, or persistent cervical cancer.
- Being tested
- Camrelizumab, Apatinib, Paclitaxel, Cisplatin, Carboplatin
- 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.
CamrelizumabDrug
Also called SHR1210
IV injection
ApatinibDrug
Oral
PaclitaxelDrug
IV injection
CisplatinDrug
IV infusion
CarboplatinDrug
IV infusion
BevacizumabDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab + Apatinib | Experimental | On Day 1 and Day 15 of each 28-day cycle, participants receive an intravenous (IV) infusion of camrelizumab 200 mg Plus an oral apatinib 250 mg once daily. Apatinib will be administered 250 mg once every other day when completing twice tumor assessement. All treatments are administered until disease progression or unacceptable toxicity. Receives: Drug: Camrelizumab; Drug: Apatinib |
| Paclitaxel + Cisplatin/Carboplatin + Bevacizumab | Active comparator | On Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH bevacizumab 15 mg/kg OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5, WITH bevacizumab 15 mg/kg). All treatments are administered until disease progression or unacceptable toxicity. Receives: Drug: Paclitaxel; Drug: Cisplatin; Drug: Carboplatin; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS defined as the time from randomization to the first documented disease progression per RECIST v1.1, or death due to any cause, whichever occurs first.
Measured: up to 36 months
Secondary outcomes (6)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants in the analysis population who have a complete response or a partial response per RECIST 1.1.
Measured: up to 24 months
Duration of Response (DOR)
DOR is defined as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.
Measured: up to 24 months
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who have CR, PR, and stable disease (SD).
Measured: up to 24 months
Overall Survival (OS)
OS is defined as the time from the treatment to death due to any cause.
Measured: up to 48 months
Number of Subjects with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Measured: up to 48 months
Patient-reported outcomes (PROs)
PROs assessed by the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI).
The Functional Assessment of Cancer Therapy-General (FACT-G) is a 27-item self-report quality of life (QOL) measure that includes 4 subscales (physical well-being, social well-being, functional well-being and emotional well-being). The Trial Outcome of Index of FACT-Cx (FACT-Cx TOI) consists of two subscales from the FACT-G: Physical Well Being (7 items) and Functional Well Being (7 items), plus the Cervix Cancer-specific subscale (15 items). The total score is ranged 0-116 for FACT-Cx TOI. A higher score indicates better HRQL.
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start30 Jul 2021
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Why it stopped: No superior PFS in study group among the enrolled patients. Company R\&D strategy shifted; funding discontinued, study terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IVB 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen University Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunyan Lan，MD, Sun Yat-Sen University Cancer Center
- Investigators
- Xin Huang, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974944
- Sponsor's protocol ID
- B2021-145-01
- Status last verified
- Sep 2021
- First submitted
- 16 Jul 2021
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 2 Randomized Trial of Camrelizumab (SHR1210) Plus Apatinib Versus Paclitaxel and Cisplatin/Carboplatin Plus Bevacizumab as a First-line Therapy in Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
- ClinicalTrials.gov ID
- NCT04974944
- Acronym / sponsor ID
- B2021-145-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No superior PFS in study group among the enrolled patients. Company R\&D strategy shifted; funding discontinued, study terminated.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sun Yat-Sen University Cancer CenterUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 23 Jul 2021 (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.
Cervical cancer is the second-most common cancer in the world and is a leading cause of cancer death among women in developing countries. Cisplatin-based chemotherapy +/- bevacizumab have been recommended as the first-line treatment for patients who present with metastatic (e.g. stage IVB), persistent, or recurrent cervical cancer. However, patients in this setting are rarely curable. The immune checkpoint inhibitor (ICI) therapy, including cytotoxic T-lymphocyte antigen 4 (CTLA-4), programmed death-1 (PD-1), and programmed death-ligand 1 (PD-L1) inhibitors, has revolutionized the treatment of several cancers. The investigator previously reported the promising antitumor efficacy of camrelizumab (PD-1 inhibitor) combined with apatinib (VEGFR2 inhibitor) as second-line, or later, therapy in patients with advanced cervical cancer. This randomized study is to assess the efficacy and safety of first-line treatment with camrelizumab plus apatinib compared to the efficacy and safety of paclitaxel and cisplatin/carboplatin plus bevacizumab in patients with stage IVB, recurrent, or persistent cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab + Apatinib | Experimental | Drug: Camrelizumab, Drug: ApatinibOn Day 1 and Day 15 of each 28-day cycle, participants receive an intravenous (IV) infusion of camrelizumab 200 mg Plus an oral apatinib 250 mg once daily. Apatinib will be administered 250 mg once every other day when completing twice tumor assessement. All treatments are administered until disease progression or unacceptable toxicity. |
| Paclitaxel + Cisplatin/Carboplatin + Bevacizumab | Active comparator | Drug: Paclitaxel, Drug: Cisplatin, Drug: Carboplatin, Drug: BevacizumabOn Day 1 of each 21-day cycle, participants receive an intravenous (IV) infusion of paclitaxel 175 mg/m^2 PLUS cisplatin 50 mg/m^2 WITH bevacizumab 15 mg/kg OR paclitaxel 175 mg/m^2 PLUS carboplatin Area Under the Curve (AUC) 5, WITH bevacizumab 15 mg/kg). All treatments are administered until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed Informed Consent Form (ICF)
- Age ≥ 18 years and ≤ 70 years
- Patients must have primary stage IVB, recurrent or persistent squamous cell carcinoma of the cervix which has not been treated with systemic chemotherapy and is not amenable to curative treatment with surgery and/or radiation therapy NOTE: Prior adjuvant therapy is NOT counted as a systemic chemotherapeutic regimen for management of recurrent, persistent or metastatic carcinoma of the cervix; adjuvant therapy includes cisplatin given concurrent with primary radiation therapy (CCRT) and adjuvant chemotherapy given following the completion of concurrent chemotherapy and radiation therapy
- Patients must have measurable disease per RECIST v1.1; measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded as ≥ 10 mm with computed tomography (CT) scan, magnetic resonance imaging (MRI); a lymph node must be ≥ 15 mm in short axis. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
- Life expectancy exceeds 12 weeks.
Key exclusion criteria (23 listed)
- Has an active autoimmune disease that has required systemic treatment; replacement therapy is not considered a form of systemic treatment.
- Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Has pleural effusion and ascites that require punctured and drained. However, an exception includes patients with pleural effusion and ascites who have no symptoms.
- Has bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. Ureteral stent placement must be performed in patients with unilateral hydronephrosis prior to enrollment.
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 |
|---|---|---|
| CamrelizumabAlso: SHR1210IV injection | Drug | Camrelizumab + Apatinib |
| ApatinibOral | Drug | Camrelizumab + Apatinib |
| PaclitaxelIV injection | Drug | Paclitaxel + Cisplatin/Carboplatin + Bevacizumab |
| CisplatinIV infusion | Drug | Paclitaxel + Cisplatin/Carboplatin + Bevacizumab |
| CarboplatinIV infusion | Drug | Paclitaxel + Cisplatin/Carboplatin + Bevacizumab |
| BevacizumabIV infusion | Drug | Paclitaxel + Cisplatin/Carboplatin + Bevacizumab |
Primary outcome
Progression-Free Survival (PFS)
Time frame: up to 36 months
PFS defined as the time from randomization to the first documented disease progression per RECIST v1.1, or death due to any cause, whichever occurs first.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 24 months
Duration of Response (DOR)
Time frame: up to 24 months
Disease Control Rate (DCR)
Time frame: up to 24 months
Overall Survival (OS)
Time frame: up to 48 months
Number of Subjects with treatment-related adverse events (AEs)
Time frame: up to 48 months
Patient-reported outcomes (PROs)
Time frame: up to 48 months
Results and safety
The study was stopped early (reason given: No superior PFS in study group among the enrolled patients. Company R\&D strategy shifted; funding discontinued, study terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Xin Huang, MD principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab, Apatinib and Paclitaxel in people with Stage IVB Cervical Cancer and Recurrent Cervical Cancer, run by Sun Yat-Sen University Cancer Center 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 11 inclusion and 23 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: stopped early, as of the sponsor's last update on 29 Jul 2026. 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. 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?
The study was stopped early (reason given: No superior PFS in study group among the enrolled patients. Company R\&D strategy shifted; funding discontinued, study terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: up to 36 months). 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 29 Jul 2026.