Can an immunotherapy-angiogenesis combo outshine standard chemo for advanced cervical cancer?
NCT ID NCT04974944
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This phase 2 trial compares a new combination of camrelizumab (an immunotherapy) plus apatinib (a targeted therapy) against the standard chemotherapy plus bevacizumab as a first treatment for women with stage IVB, recurrent, or persistent cervical cancer. The study aims to see if the new combo can delay cancer progression better than the current approach. About 35 participants will be randomly assigned to one of the two treatment groups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- camrelizumab plus apatinib
- What this could lead to
- If successful, this combination could offer a new first-line treatment option for advanced cervical cancer that may be more effective than current standard therapy.
- What could go wrong
- This is a small phase 2 trial, so results may not confirm benefit. The combination also carries risks of immune-related side effects and high blood pressure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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35 people
The number who actually took part.
- Started
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Jul 2021
- Finished
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Jan 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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 Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New combo therapy offers hope for advanced cervical cancer patients