Cervical CancerPhase 2NCT05259540
Effect of Compound Kushen Injection Combined With Pabolizumab in the Treatment of Cervical Adenocarcinoma
A Phase 2 study testing compound kushen injection combined with pabolizumab in people with Cervical Cancer, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
In the past few decades, the incidence of endocervical adenocarcinomas (ECAs) has been on the rise both in absolute numbers and overall proportion in cervical cancers. ECAs remain a significant public health problem despite advances in treatment options. 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?
- compound kushen injection combined with pabolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 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
- Female, aged ≥ 18 yrs and ≤75 yrs;
- Patients volunteered to participate in this study, signed informed consent, good compliance, and cooperated with follow-up;
- The subjects' damage caused by other treatments has been recovered (NCI CTCAE version 5.0 grade ≤ grade 1), ECOG score ≤ 2 points;
- Expected survival is longer than 3 months;
- Pathological diagnosis of cervical advanced adenocarcinoma (PD-L1 positive, TPS score ≥1%; CPS score ≥1);
- Evaluable lesions: CT scan of tumor lesions ≥5mm in length, CT scan of lymph node lesions ≥10mm in length, and scan layer thickness not greater than 5mm (refer to RECIST 1.1);
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- The first diagnosis was confirmed by pathology and / or cytology to be metastatic, or recurrent, persistent cervical adenocarcinoma (mainly refers to tumors remaining or progressing at least 3 months after initial radiotherapy or concurrent chemoradiotherapy), and the patient can no longer accept Surgery or chemoradiation;
- Subject agrees to take blood sample;
- Subjects can provide formalin-fixed, paraffin-embedded tumor tissue samples for subsequent related testing (optional);
- A.Complete blood count: hemoglobin (Hb) ≥90g/L ; absolute neutrophil count (ANC) ≥1.0×109/L ; platelets >=100×109/L B. Biochemical test standards: a. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 times the upper limit of normal value (ULN). If with liver metastases, ALT and AST ≤ 5 × ULN; b. Total bilirubin (TBIL) ≤ 1.5 × ULN; c. Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 60ml / min; d. Doppler ultrasound evaluation: left ventricular ejection Blood fraction (LVEF) ≥ the lower limit of normal value (50%).
- Women of childbearing age should agree that contraception (such as an intrauterine device, contraceptive, or condom) must be used during the study and within 3 months after the last dose; a serum or urine pregnancy test must be negative within 14 days of study enrollment and must be Non-lactating patients. Sign written informed consent before conducting any research-related procedures.
Who cannot join
- People who are known to be allergic to compound kushen injection and pabolizumab or to active or inactive ingredients of drugs with similar chemical structures to compound kushen injection and pabolizumab.
- Symptomatic, uncontrolled brain metastases or pia meningeal metastases.
- No imaging scan is required to confirm brain-free metastases; patients with spinal cord compression may still be considered if they have received targeted treatment and have evidence of clinical stability of the disease for at least> 28 days (controlled central nervous system metastasis must be in the study Have received treatment such as radiation or chemotherapy for at least 1 month; patients must not have new symptoms related to central nervous system lesions or symptoms that indicate disease progression, and patients either take a stable dose of hormones or do not need to take hormones).
- Underwent major surgery within 3 weeks before the study began, or any surgical effects that have not recovered after surgery, or received chemotherapy.
- Received> 20% bone marrow palliative radiotherapy 1 week before enrollment.
- Have aggressive cancers other than cervical cancer (except fully treated basal or squamous cell skin cancer within 2 years before enrollment).
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- Patient has a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- Suffering from a serious or uncontrolled illness, including but not limited to:
- 1. Uncontrollable nausea and vomiting, inability to swallow research drugs, and any gastrointestinal disorders that may interfere with the metabolism of the drug.
- 2. Active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.
- 3. Uncontrolled major seizures, unstable spinal cord compression, superior vena cava syndrome, or other mental illnesses that prevent patients from signing informed consent.
- 4. Immunodeficiency (except splenectomy), or other diseases that the investigator believes may expose patients to high-risk toxicity.
- 9. History of bleeding and thrombosis:
- Any CTCAE Grade 2 bleeding event within 3 months prior to screening, or CTCAE Grade 3 and above bleeding events within 6 months prior to screening.
- History of gastrointestinal bleeding or clear gastrointestinal bleeding tendency within 6 months before screening. Such as: esophageal varices at risk of bleeding, focal lesions of locally active ulcers, or fecal occult blood +.
- Have active bleeding or coagulopathy, have a tendency to bleed, or are receiving thrombolytic or anticoagulant therapy.
- Patients need anticoagulation with drugs such as warfarin or heparin.
- Patients need long-term antiplatelet therapy (eg aspirin, clopidogrel).
- Thrombosis or embolism events in the past 6 months, such as: cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism.
- 10. Serious cardiovascular history:
- NYHA (New York Heart Association) Grade 3 and 4 congestive heart failure.
- Suffering from unstable angina or newly diagnosed angina or myocardial infarction within 12 months before screening.
- Arrhythmias requiring therapeutic intervention (patients taking beta-blockers or digoxin can be enrolled).
- CTCAE≥ grade 2 valvular heart disease.
- 11. Poorly controlled hypertension (systolic blood pressure> 150 mmHg or diastolic blood pressure> 100 mmHg).
- 12. Other laboratory inspection abnormalities:
- Hyponatremia (sodium <130 mmol / L); baseline serum potassium <3.5 mmol / L (before entering the study, potassium supplements can be used to restore serum potassium above this level).
- Abnormal thyroid function, and drugs cannot maintain thyroid function within normal range.
- 13. Any previous or current disease, treatment, or laboratory abnormality that may interfere with the results of the study, affect the patient's full participation in the study, or the investigator believes that the patient is not suitable to participate in the study; the patient may not receive platelets within 4 weeks before the study drug begins Red blood cell infusion.
- 14. Patients who are pregnant or breastfeeding, or plan to become pregnant during study treatment.
- 15. Corrected QTc interval (QTc)> 450 milliseconds; if the patient has a prolonged QTc interval, but the investigator evaluates that the reason for the prolongation is a pacemaker (and no other cardiac abnormalities), it is necessary to discuss with the investigator to determine whether the patient is suitable Group study.
- 16. With any active autoimmune disease or have a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or asthma has been completely relieved in childhood and do not need any intervention after adulthood could be included; Asthma patient who need bronchodilators for medical intervention cannot be included) 17. Treatment with other immunosuppressive medications, systemic or topical corticosteroids (>10 mg daily prednisone or equivalent) within 14 days before enrollment.
- 18. With a history of severe allergic reaction to other monoclonal antibodies. 19. Evidence of central nervous system metastasis (such as brain edema requiring hormone intervention, or brain metastasis progression). Patients who have previously received treatment for brain or meningeal metastasis and persistently stable (MRI) for at least 1 month thus stopped systemic hormone therapy (dose > 10mg/ prednisone or other therapeutic hormones) for more than 2 weeks can be included.
- 20. Have previously received any PD-1/PD-L1 inhibitor treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
Lili Chen
Hangzhou, Zhejiang, 310006
Lili Chen, Doctor, 8657187061501, 5197004@zju.edu.cn
About this study
Official title: Effect of Compound Kushen Injection Combined With Pabolizumab in the Treatment of Cervical Adenocarcinoma: A Phase II Single-arm Clinical Study
In the past few decades, the incidence of endocervical adenocarcinomas (ECAs) has been on the rise both in absolute numbers and overall proportion in cervical cancers. ECAs remain a significant public health problem despite advances in treatment options. Patients with ECA have a poorer survival rate than patients with squamous cell carcinoma (SCC), especially in patients with metastatic tumors. In the newly published 2020 World Health Organization (WHO) Classification of Female Genital Tumors, ECAs are subclassified into human papillomavirus-associated (HPVA) and human papillomavirus-independent (HPVI) groups. Meanwhile, PD-1/PD-L1 immunotherapy has been approved for the treatment of advanced cervical cancer, but there are still many deficiencies. Therefore, the investigators plan to use the new classification of female genital tumors and conduct a clinical trial to explore the safety and effectiveness of compound kushen injection combined with pabolizumab in the treatment of metastatic, recurrent, persistent cervical adenocarcinoma.
Read the detailed description
In this study, PD-1 inhibitors (pabolizumab) combined with compound kushen injection were used to treat metastatic, recurrent, persistent cervical adenocarcinoma, and the efficacy and safety of the two drugs were evaluated.
Participants who meet the requirements will sign the informed consent and be enrolled voluntarily. This project is a single-arm study without a control group. Forty-two patients are expected to be enrolled.
Two scoring systems, the combined positive score (CPS) and the tumor proportion score (TPS), are used for evaluation of PD-L1 expression of solid tumors. Through the measurable changes in the size of the lesions, the investigators can understand the changes of the disease. The primary endpoints were PFS and ORR. Whenever, for whatever reason, the subject does not complete the clinical trial observation, is considered to be an abscission case. When the subject falls off, the investigators must fill in the reason for the fall off in the CRF, and contact the subject as much as possible, complete the items that can be evaluated, and record the time of the last medication to prepare for the analysis of its efficacy and safety. The CRF should be kept for future reference.
- Conditions
- Cervical Cancer
- Being tested
- compound kushen injection combined with pabolizumab
- Keywords
- PD1, PD-L1, Cervical adenocarcinoma
- 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.
compound kushen injection combined with pabolizumabDrug
Also called experience group
compound kushen injection 20ml/day and pabolizumab 200mg/21 days, both drugs are given intravenously
| Study group | Role | What they receive |
|---|---|---|
| compound kushen injection combined with pabolizumab | Experimental | compound kushen injection 20ml/day and pabolizumab 200mg/21 days Receives: Drug: compound kushen injection combined with pabolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
To evaluate the objective response rate (CR + PR) of compound kushen injection combined with pabolizumab in patients with cervical adenocarcinoma.
Measured: 12 weeks
Secondary outcomes (3)
PFS
progression-free survival
Measured: 6 months
DCR
disease control rate
Measured: 6 months
DOR
duration of response
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2025 (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 (4)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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lili Chen, MD, Principal investigator, Zhejiang University School of Medicine Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259540
- Sponsor's protocol ID
- 20210164
- Status last verified
- Mar 2022
- First submitted
- 17 Feb 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen L, Niu Y, Wan X, Yu L, Zhang X, Strickland AL, Dong L, Zhou F, Lu W. Clinicopathological features and outcomes in gastric-type of HPV-independent endocervical adenocarcinomas. BMC Cancer. 2021 Oct 11;21(1):1095. doi: 10.1186/s12885-021-08792-7.
PubMed 34635081Chen L, Lucas E, Zhang X, Liu Q, Zhuang Y, Lin W, Chen H, Zhou F. Programmed death-ligand 1 expression in human papillomavirus-independent cervical adenocarcinoma and its prognostic significance. Histopathology. 2022 Jan;80(2):338-347. doi: 10.1111/his.14552. Epub 2021 Oct 13.
PubMed 34455625Frenel JS, Le Tourneau C, O'Neil B, Ott PA, Piha-Paul SA, Gomez-Roca C, van Brummelen EMJ, Rugo HS, Thomas S, Saraf S, Rangwala R, Varga A. Safety and Efficacy of Pembrolizumab in Advanced, Programmed Death Ligand 1-Positive Cervical Cancer: Results From the Phase Ib KEYNOTE-028 Trial. J Clin Oncol. 2017 Dec 20;35(36):4035-4041. doi: 10.1200/JCO.2017.74.5471. Epub 2017 Nov 2.
PubMed 29095678Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Xu L, Zeigenfuss S, Pruitt SK, Leary A. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2019 Jun 10;37(17):1470-1478. doi: 10.1200/JCO.18.01265. Epub 2019 Apr 3.
PubMed 30943124
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Compound Kushen Injection Combined With Pabolizumab in the Treatment of Cervical Adenocarcinoma: A Phase II Single-arm Clinical Study
- ClinicalTrials.gov ID
- NCT05259540
- Acronym / sponsor ID
- 20210164
- Conditions
- Cervical Cancer
- Keywords
- PD1, PD-L1, Cervical adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Feb 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.
In the past few decades, the incidence of endocervical adenocarcinomas (ECAs) has been on the rise both in absolute numbers and overall proportion in cervical cancers. ECAs remain a significant public health problem despite advances in treatment options. Patients with ECA have a poorer survival rate than patients with squamous cell carcinoma (SCC), especially in patients with metastatic tumors. In the newly published 2020 World Health Organization (WHO) Classification of Female Genital Tumors, ECAs are subclassified into human papillomavirus-associated (HPVA) and human papillomavirus-independent (HPVI) groups. Meanwhile, PD-1/PD-L1 immunotherapy has been approved for the treatment of advanced cervical cancer, but there are still many deficiencies. Therefore, the investigators plan to use the new classification of female genital tumors and conduct a clinical trial to explore the safety and effectiveness of compound kushen injection combined with pabolizumab in the treatment of metastatic, recurrent, persistent cervical adenocarcinoma.
Detailed description
In this study, PD-1 inhibitors (pabolizumab) combined with compound kushen injection were used to treat metastatic, recurrent, persistent cervical adenocarcinoma, and the efficacy and safety of the two drugs were evaluated.
Participants who meet the requirements will sign the informed consent and be enrolled voluntarily. This project is a single-arm study without a control group. Forty-two patients are expected to be enrolled.
Two scoring systems, the combined positive score (CPS) and the tumor proportion score (TPS), are used for evaluation of PD-L1 expression of solid tumors. Through the measurable changes in the size of the lesions, the investigators can understand the changes of the disease. The primary endpoints were PFS and ORR. Whenever, for whatever reason, the subject does not complete the clinical trial observation, is considered to be an abscission case. When the subject falls off, the investigators must fill in the reason for the fall off in the CRF, and contact the subject as much as possible, complete the items that can be evaluated, and record the time of the last medication to prepare for the analysis of its efficacy and safety. The CRF should be kept for future reference.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| compound kushen injection combined with pabolizumab | Experimental | Drug: compound kushen injection combined with pabolizumabcompound kushen injection 20ml/day and pabolizumab 200mg/21 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female, aged ≥ 18 yrs and ≤75 yrs;
- Patients volunteered to participate in this study, signed informed consent, good compliance, and cooperated with follow-up;
- The subjects' damage caused by other treatments has been recovered (NCI CTCAE version 5.0 grade ≤ grade 1), ECOG score ≤ 2 points;
- Expected survival is longer than 3 months;
- Pathological diagnosis of cervical advanced adenocarcinoma (PD-L1 positive, TPS score ≥1%; CPS score ≥1);
Key exclusion criteria (34 listed)
- People who are known to be allergic to compound kushen injection and pabolizumab or to active or inactive ingredients of drugs with similar chemical structures to compound kushen injection and pabolizumab.
- Symptomatic, uncontrolled brain metastases or pia meningeal metastases.
- No imaging scan is required to confirm brain-free metastases; patients with spinal cord compression may still be considered if they have received targeted treatment and have evidence of clinical stability of the disease for at least> 28 days (controlled central nervous system metastasis must be in the study Have received treatment such as radiation or chemotherapy for at least 1 month; patients must not have new symptoms related to central nervous system lesions or symptoms that indicate disease progression, and patients either take a stable dose of hormones or do not need to take hormones).
- Underwent major surgery within 3 weeks before the study began, or any surgical effects that have not recovered after surgery, or received chemotherapy.
- Received> 20% bone marrow palliative radiotherapy 1 week before 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 |
|---|---|---|
| compound kushen injection combined with pabolizumabAlso: experience groupcompound kushen injection 20ml/day and pabolizumab 200mg/21 days, both drugs are given intravenously | Drug | compound kushen injection combined with pabolizumab |
Primary outcome
ORR
Time frame: 12 weeks
To evaluate the objective response rate (CR + PR) of compound kushen injection combined with pabolizumab in patients with cervical adenocarcinoma.
3 secondary outcomes
PFS
Time frame: 6 months
DCR
Time frame: 6 months
DOR
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Background: PubMed 34635081Chen L, Niu Y, Wan X, Yu L, Zhang X, Strickland AL, Dong L, Zhou F, Lu W. Clinicopathological features and outcomes in gastric-type of HPV-independent endocervical adenocarcinomas. BMC Cancer. 2021 Oct 11;21(1):1095. doi: 10.1186/s12885-021-08792-7.
- Background: PubMed 34455625Chen L, Lucas E, Zhang X, Liu Q, Zhuang Y, Lin W, Chen H, Zhou F. Programmed death-ligand 1 expression in human papillomavirus-independent cervical adenocarcinoma and its prognostic significance. Histopathology. 2022 Jan;80(2):338-347. doi: 10.1111/his.14552. Epub 2021 Oct 13.
- Background: PubMed 29095678Frenel JS, Le Tourneau C, O'Neil B, Ott PA, Piha-Paul SA, Gomez-Roca C, van Brummelen EMJ, Rugo HS, Thomas S, Saraf S, Rangwala R, Varga A. Safety and Efficacy of Pembrolizumab in Advanced, Programmed Death Ligand 1-Positive Cervical Cancer: Results From the Phase Ib KEYNOTE-028 Trial. J Clin Oncol. 2017 Dec 20;35(36):4035-4041. doi: 10.1200/JCO.2017.74.5471. Epub 2017 Nov 2.
- Background: PubMed 30943124Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Xu L, Zeigenfuss S, Pruitt SK, Leary A. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2019 Jun 10;37(17):1470-1478. doi: 10.1200/JCO.18.01265. Epub 2019 Apr 3.
- 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.
Lili Chen, MD principal investigator
Zhejiang University School of Medicine Women's Hospital
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 compound kushen injection combined with pabolizumab in people with Cervical Cancer, run by Women's Hospital School Of Medicine Zhejiang University 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 34 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 24 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lili Chen, MD (8657187061501, 5197004@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 12 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 NCT05259540, which also lists 4 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 24 Mar 2022.