AzTrials
AzTrials

Gynecological CancerPhase 2ALTER-GO-020NCT05028504

A Phase II Study of Anlotinib Combined With Penpulimab in Subjects With Gynecological Cancer

A Phase 2 study testing Penpulimab and Anlotinib in people with Gynecological Cancer, run by Sichuan Cancer Hospital and Research Institute at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a single-arm, open-label, phase II clinical trial to evaluate the efficacy and safety of penpulimab combined with anlotinib in subjects with gynecological cancer, including 23 ovarian cancer，37 endometrial cancer，26 cervical cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Gynecological Cancer
What is being tested?
Penpulimab and Anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
6 sitesChina
Study dates
10 May 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

  • Understood and signed an informed consent form;
  • 18 years and older, female, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, life expectancy ≥3 months;
  • Histopathologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer; or endometrial cancer; or cervical cancer (including squamous cell, adenocarcinoma, or adenosquamous cell carcinoma);
  • Patients must also meet any of the following conditions:
  • Platinum-resistant relapsed or platinum-refractory ovarian cancer, the patient has received at least 1 line of platinum-based chemotherapy after previous cytoreductive surgery;
  • With residual disease after surgery or inoperable stage III-IV endometrial cancer, and refused to receive chemoradiation/radiation/chemotherapy; or recurrent endometrial cancer unsuitable or refusing standard therapy;
Show all 15Show fewer
  • Persistent cervical cancer unsuitable for curative treatment, or recurrent/metastatic cervical cancer that refuses to receive standard treatment (for recurrent disease, not yet treated).
  • At least one measurable lesion according to the RECIST 1.1;
  • Try to provide tumor tissue samples for PD-L1 testing (not required)；
  • Demonstrates adequate organ function:
  • Blood routine inspection: Hemoglobin (HB) >= 90 g/L; The absolute value of neutrophil (ANC) >= 1.5x10^9/L;Platelets (PLT) >= 100x10^9/L;
  • Blood biochemical inspection: Serum creatinine (Cr) <= 1.5 ULN, or creatinine clearance (CCr) >= 60mL / min; Total bilirubin (TBIL) <= 1.5 ULN, or direct bilirubin <= 1.0 ULN; AST and ALT <= 2.5 ULN.
  • Blood coagulation function: Activated partial thromboplastin time, international standardized ratio adn prothrombin time <=1.5 ULN;
  • Cardiac Function: left ventricular ejection fraction (LVEF) >=50%;
  • Women of child-bearing potential must agree to use contraceptive measures (such as intrauterine devices or condoms) during the study and for 6 months after the end of the study, and have a negative serum pregnancy test within 7 days of enrollment, and must be non lactating subjects.

Who cannot join

  • Has other non-epithelial ovarian tumors or borderline ovarian epithelial tumors; has carcinosarcoma, endometrial leiomyosarcoma, endometrial stromal sarcoma, or other high-grade sarcoma; has small cell carcinoma of the cervix, or clear cell carcinoma;
  • Other malignant tumors that have appeared or are currently present within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors;
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137);
  • Has received prior therapy with tyrosine kinase inhibitors that target VEGFR, such as pazopanib, sorafenib, regorafenib, apatinib and other drugs; but previous bevacizumab treatment is allowed (only for ovarian cancer cohorts), provided that the treatment is stopped for more than 4 weeks before enrollment;
  • Has received prior radiotherapy within 4 weeks prior to enrollment (participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis - a 2-week washout is permitted for palliative radiation to non-CNS disease and vaginal brachytherapy);
  • Has received prior hormonal therapy for the treatment of endometrial carcinoma within 1 week before enrollment;
Show all 28Show fewer
  • Expect to use any active vaccine against infectious diseases (such as influenza vaccine, chickenpox vaccine, etc.) within 28 days before the first dose or during the study period;
  • Patients received systemic glucocorticoid therapy or other immunosuppressive therapy (dose> 10mg / day prednisone or other effective hormones) within 14 days before the first dose;
  • Active autoimmune diseases that require systemic treatment have occurred within 2 years before the first dose;
  • Subjects known to be allergic to the study drug or any of its excipients or have experienced a severe allergic reaction to other monoclonal antibodies;
  • Has uncontrollable symptoms of brain metastases, spinal cord compression, cancerous meningitis;
  • Has any bleeding or bleeding event ≥ CTC AE Grade 3 or unhealed wounds, ulcers or fractures within 4 weeks before enrollment;
  • Patients with a clear tendency to gastrointestinal bleeding；
  • Suspected or definite presence of symptoms or signs of radiation enteritis, and recurrence within 1 year from the end of radiotherapy;
  • Patients whose tumors have invaded large blood vessels or poorly demarcated from the blood vessels according to imaging findings (CT/MRI);
  • Prophylactic use of low dose aspirin (≤100mg/d) and low molecular weight heparin (≤40mg/d) is permitted in patients undergoing thrombolysis or anticoagulant therapy;
  • Has clinically significant thyroid dysfunction before enrollment;
  • Has multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
  • Has any severe acute complications before enrollment:
  • Blood pressure control is not ideal (systolic pressure >= 150 mmHg, diastolic pressure >= 100 mmHg);
  • Patients had Unstable angina pectoris, myocardial infarction, ≥grade 2 congestive heart failure, or arrhythmia requiring treatment (including QTc ≥480 ms) within 6 months before enrollment;
  • Active or uncontrolled serious infection (≥CTC AE grade 2 infection);
  • Epidemiological test results during the screening period showed that any of the following is met: * HBsAg positive and HBV DNA exceeds the upper limit of normal value (those who fall within the normal range after antiviral treatment can be included); * Anti-HCV positive and HCV RNA positive; * HIV positive;
  • Poorly controlled diabetes (fasting blood glucose ≥ grade 2);
  • Had an arterio / venous thrombotic / carcinothrombotic event within 6 months, such as cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, and Hypertensive crisis or hypertensive encephalopathy;
  • Exacerbated chronic obstructive pulmonary disease (COPD) or other respiratory diseases that require hospitalization, or have active lung infections and/or acute bacterial or fungal infections that require intravenous antibiotic treatment within 28 days before the first dose.
  • Has participated in other anti-tumor intervention clinical trials within 4 weeks before the first medication;
  • According to the judgement of the researchers, there are other factors that may lead to the termination of the study. For example, other serious diseases including mental disorders need to be treated together, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of data and samples.

Trial locations and contacts

6 sites in 1 country.

Guonan Zhang contact

86-13881866599

zhanggn@hotmail.com

Hong Liu contact

86-13693447854

liuhaotian12@163.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Yang Xiang, 010-69156068, XiangY@pumch.cn

    Ninghai Cheng

    Recruiting

  • Sicchuan cancer hospital

    Chengdu, Sichuan, 610000

    Guonan Zhang, 86-13881866599, zhanggn@hotmail.com

    Hong Liu, 86-13693447854

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangdong, Guangdong, 510080

    Mian He, 86-13719000300

    Peng Guo

    Recruiting

  • The First Affiliated Hospital of USTC, Anhui Provincial Hospital

    Hefei, Hefei

    Weidong Zhao, 86-13955105591

    Zhengzheng Chen

    Recruiting

  • Shaanxi Provincial Cancer Hospital

    Xi’an, Shanxi

    Guoqing Wang, 86-13892828647

    Lijuan Hu

    Not yet recruiting

  • Shaanxi Provincial People's Hospital

    Xi’an, Shanxi

    Lihong Chen, 86-13689280015

    Fen Li

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Open-label, Multi-cohort, Multi-center Phase II Clinical Study of Anlotinib Combined With Penpulimab in the Treatment of Recurrent or Metastatic Gynecological Cancer

This is a single-arm, open-label, phase II clinical trial to evaluate the efficacy and safety of penpulimab combined with anlotinib in subjects with gynecological cancer, including 23 ovarian cancer，37 endometrial cancer，26 cervical cancer.

Being tested
Penpulimab, Anlotinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PenpulimabDrug

    Penpulimab is a humanized monoclonal antibody targeting programmed cell death-1 (PD-1), which prevents PD-1 from binding to PD-L1 and PD-L2 receptors on tumor cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

  • AnlotinibDrug

    A multi-target receptor tyrosine kinase inhibitor

Study groups in NCT05028504
Study groupRoleWhat they receive
Penpulimab+AnlotinibExperimentalPenpulimab 200 mg IV on Day 1 of each 21-day cycle plus Anlotinib capsules 12mg given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
Receives: Drug: Penpulimab; Drug: Anlotinib

What is being measured

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

  1. Objective Response Rate (ORR)

    Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)

    Measured: up to 96 weeks

Secondary outcomes (4)

  1. Progression free survival (PFS)

    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

    Measured: up to 96 weeks

  2. Duration of Response (DOR)

    Time from tumor first assessment to CR or PR to first assessment to PD (Progressive Disease) or death from any cause

    Measured: up to 96 weeks

  3. Disease control rate（DCR）

    Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).

    Measured: up to 96 weeks

  4. Overall Survival (OS)

    OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

    Measured: up to 120 weeks

Timeline

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

  1. First posted31 Aug 2021
  2. Study start10 May 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (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
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05028504
Sponsor's protocol ID
ALTERGO020
Acronym
ALTER-GO-020
Status last verified
Dec 2023
First submitted
25 Aug 2021
Last updated
27 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Penpulimab and Anlotinib in people with Gynecological Cancer, run by Sichuan Cancer Hospital and Research Institute at 6 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 15 inclusion and 28 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 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 96 weeks). 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 NCT05028504.

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 27 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in