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Cervical CancerPhase 2NCT05137171

AK105 Combined With Anlotinib in Patients With Cervical Cancer

A Phase 2 study testing AK105 and anlotinib in people with Cervical Cancer, run by The First Affiliated Hospital of Zhengzhou University at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of AK105 (anti-PD-1 mab) combined with Anlotinib Hydrochloride in the treatment of persistent, recurrent and 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?
AK105 and anlotinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesChina
Study dates
2 May 2022to 31 Dec 2027
Phase
Phase 2
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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients voluntarily participated in the study and signed informed consent;
  • Age between 18 and 75;
  • Agreed to detect the expression status of PD-L1 biomarker;
  • ECOG score is 0 or 1, and the expected survival time is not less than 3 months;
  • Histologically confirmed recurrent or metastatic squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma with documented disease progression. Note that histological confirmation of the original primary tumor is required by pathological reports;
  • Patients with recurrent or metastatic cervical cancer who had received at least once platinum-based systemic chemotherapy in the curative setting were included;
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  • The patient is not suitable for local treatment (surgery or radiotherapy cannot be performed);
  • Patients with measurable lesions as defined in RECIST1.1 criteria;
  • The main organs function is well, and the laboratory test indexes meet the following requirements:(1) Routine blood test (no blood transfusion or hematopoietic stimulating factor was used within 7 days before screening) :① Hemoglobin (HB) ≥ 90g/L;② Absolute neutrophil count (ANC) ≥1.5×109/L;③ Platelet (PLT) ≥ 80×109/L;(2) Blood biochemical test (no blood transfusion or albumin within 7 days before screening) :① ALT and AST ≤2.5 × ULN (liver/bone metastasis ≤5 × ULN;Bone metastases ≤5 ULN);② Serum total bilirubin (TBIL) ≤1.5 × ULN;③ Serum Cr≤1.5×ULN or creatinine clearance ≥60 mL /min;(3) Coagulation function test:① Activated partial thrombin time (APTT), international standardized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN;② Doppler ultrasound assessment: left ventricular ejection fraction (LVE F)≥ 50%;
  • Any toxic side effects of previous chemotherapy have been recovered to ≤CTCAE1 or baseline level;
  • The patient has the ability to take medication orally;
  • Women of reproductive age must agree to use a highly effective method of contraception during the study period and for 6 months after the last administration of the study drug;Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects;

Who cannot join

  • Patients with a history or signs of brain metastases;
  • Prior use of bevacizumab, antiangiogenic drugs and other antiangiogenic drugs;
  • Received anti-tumor monoclonal antibody treatment within 4 weeks before enrollment; Had previously received other PD-1/PD-L1 antibodies and anti-CTLA-4 (cytotoxic T-lymphocyte associated antigen-4) therapy.
  • Patients were receiving immunosuppressant or systemic hormone therapy for immunosuppression (dose > 10mg/ day of prednisone or other equivalent hormone) and were still using 2 weeks prior to enrollment
  • Participate in other clinical trials or complete other clinical trials within 4 weeks;
  • Abnormal coagulation function (INR > 2.0, PT > 16s), bleeding tendency or receiving thrombolytic or anticoagulant therapy;
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  • Failed to recover from adverse events (except hair loss) after prior medication use;
  • The patient has any active autoimmune disease or a history of autoimmune disease;
  • Clinical symptoms or diseases of the heart that are not well controlled;
  • Congenital or acquired immune deficiency;
  • Received chemotherapy, targeted and radiotherapy within 2 weeks before enrollment;
  • Concomitant diseases/History:(1) Clinically significant hemoptysis occurred within 3 months before enrollment (hemoptysis > 50ml per day);Or bleeding symptoms of significant clinical significance or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occultation and above, or suffering from vasculitis, etc.;(2) Arteriovenous thrombosis events occurred within 6 months before enrollment, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except those who had been cured after intravenous catheterization due to chemotherapy) and pulmonary embolism, etc.;(3) hypertension, which cannot be well controlled by antihypertensive drug therapy (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg);During the first 6 months of randomization, myocardial infarction, severe/unstable angina, NYHA grade 2 or higher cardiac dysfunction, clinically significant ventricular arrhythmias or ventricular arrhythmias, and symptomatic congestive heart failure;(4) Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (e.g., diabetes, pulmonary fibrosis and acute pneumonia);(5) Renal insufficiency: urine protein ≥ ++ indicated by routine urine examination, or confirmed 24-hour urine protein level ≥1.0g; (6) History of live attenuated vaccine vaccination within 28 days prior to initial study administration or expected live attenuated vaccine vaccination during study period;(7) human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS);Active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ mL;Hepatitis C, defined as hcV-RNA higher than the lower limit of assay) or co-infection with hepatitis B and c;(8) Severe infection, including but not limited to bacteremia and severe pneumonia requiring hospitalization, occurred within 4 weeks before the first administration;Active infection with CTCAE grade ≥2 requiring systemic antibiotic treatment within 2 weeks prior to initial administration, or fever of unknown origin >38.5°C during screening/prior to initial administration (as determined by the investigator, fever due to tumor can be included);Evidence of active tuberculosis infection within 1 year before administration;(9) Have been diagnosed with any other malignant tumor within 3 years prior to entry into the study;(10) Major surgery performed within 28 days before enrollment (tissue biopsy and peripheral venipuncture placement of central venous catheter [PICC] required for diagnosis are permitted);
  • Subjects who have received or are planning to receive allogeneic bone marrow transplantation or solid organ transplantation;
  • Peripheral neuropathy ≥ grade 2;Patients with active brain metastases, cancerous meningitis, spinal cord compression, or diseases of the brain or pia meningeal found by imaging CT or MRI examination at the time of screening (patients with brain metastases who had completed treatment 14 days before enrollment and had stable symptoms could be enrolled, but were confirmed to have no symptoms of cerebral hemorrhage by craniocerebral MRI, CT or venography evaluation);
  • There are significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea, and presence of clinically significant intestinal obstruction.
  • Corrected QT interval > 470 msec;If a patient has a prolonged QT interval, but the investigator assessed the cause of the prolonged QT interval as pacemaker (and no other cardiac abnormalities), discussion with other study physicians will be required to determine whether the patient is eligible for inclusion.
  • Known allergic to pharmaceutical ingredients;
  • Female subjects who are pregnant, breast-feeding, or planning to become pregnant during the study period.
  • Patients with other serious physical or mental disorders or abnormal laboratory tests that may increase the risk of study participation or interfere with study results, and who are considered unsuitable for study participation by the investigator.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Henan Polytechnic University Affiliated Hospital/Jiaozuo Second People's Hospital

    Jiaozuo, Henan, 454000

  • Luoyang Central Hospital

    Luoyang, Henan, 471000

Other trials in China

About this study

Official title: A Single-arm, Prospective Phase II Clinical Study of the Efficacy and Safety of AK105 Combined With Anlotinib in the Treatment of Persistent, Recurrent, and Metastatic Cervical Cancer

The purpose of this study is to evaluate the efficacy and safety of AK105 (anti-PD-1 mab) combined with Anlotinib Hydrochloride in the treatment of persistent, recurrent and metastatic cervical cancer.

Read the detailed description

This is an open-label, single-arm, multicenter phase II clinical trial evaluating the efficacy and safety of AK105 (penpulimab, 200 mg IV Q3W) combined with anlotinib (12 mg orally, 2 weeks on/1 week off, Q3W) as first-line treatment for patients with persistent, recurrent, or metastatic cervical cancer (histologic types include squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma). Eligible patients have not received prior systemic therapy for recurrent or metastatic disease. Imaging assessments are performed every 3 cycles. All patients will receive treatment until radiographic progression, unacceptable toxicity, investigator or patient decision to withdraw, or non-adherence to treatment or trial procedures.

Conditions
Cervical Cancer
Being tested
AK105 and anlotinib
Keywords
AK105,anlotinib,recurrent,metastatic
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.

  • AK105 and anlotinibDrug

    Also called penpulimab and anlotinib

    AK105(penpulimab): 200mg, every 3 weeks, 21 days as a treatment cycle;Anlotinib: 12mg, 2 weeks on/1 week off, 21 days as a treatment cycle;Treatment will continue until confirmed radiographic progression,unacceptable toxicity, investigator or patient decision to withdraw, non-adherence to treatment or trial procedures.

Study groups in NCT05137171
Study groupRoleWhat they receive
AK105 and anlortinibExperimentalAK105 200mg iv q3w;anlotinib 12mg 2w on/1w off po qd;21 days as a cycle until PD,intolerable toxicity, investigator or patient decision to withdraw, non-adherence to treatment or trial procedures.
Receives: Drug: AK105 and anlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Objective Response Rate

    Measured: up to 24 months

Secondary outcomes (2)

  1. PFS

    progression-free survival

    Measured: up to 24 months

  2. OS

    overall survival

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2021
  2. Study start2 May 2022
  3. Primary completion1 Jul 2025
  4. Study completion31 Dec 2027 (estimated)

Resources

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
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05137171
Sponsor's protocol ID
ALTER-GO-025
Status last verified
Oct 2026
First submitted
15 Nov 2021
Last updated
22 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK105 and anlotinib in people with Cervical Cancer, run by The First Affiliated Hospital of Zhengzhou University at 2 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 12 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

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?

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?

ORR (time frame: up to 24 months). 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 NCT05137171.

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 22 Oct 2026.

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