Cervical CancerNCT05879796
Envafolimab Combined With Endostar and Concurrent Chemoradiotherapy for Locally Advanced Primary Cervical Cancer
An observational study of Cervical Cancer, run by Peking University Third Hospital.
Trial summary
The goal of this study is to determine efficacy and safety of envafolimab combined with Endostar and concurrent chemoradiation in the treatment of locally advanced primary cervical cancer. Thirty participants will be divided into control group (n = 15) and experimental group (n = 15). 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?
- cis-platinum, radiation and Envafolimab Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2023to 16 May 2026
- Phase
- Observational
- 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
Study population: The participants will be selected with the help of oncologists in Peking university third hospital. All participants are advanced cervical cancer.
Who may be able to join
- Patients with histologically confirmed advanced cervical cancer， FIGO 2018 clinical stages IB3/IIA2 with positive para-aortic lymph nodes 、IIB-IVA disease, patients with locally advanced cervical cancer who are judged by their physician to be eligible for concurrent chemoradiotherapy in this trial, and have not received treatment before enrollment;
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Expected life > 3 months
- LVEF≥55%
- Adequate bone marrow, hepatic and renal function including the following:
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- Haemoglobin ≥ 90g/L, absolute neutrophil count ≥ 1,500 /µL, platelets ≥100,000 /µL; Serum creatinine ≤ 1.5 x ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN in the presence of liver metastases;total bilirubin ≤ 1.5 x ULN or patients with Gilbert 's syndrome who can have total bilirubin≤ 2.5 x ULN
- Patients of childbearing potential must agree to use effective contraception during the trial, and have a negative serum or urine pregnancy test
- Non-lactating patients
- Signed informed consent
Who cannot join
- Prior treatment with an anti-PD-1, anti-PD-L1 or anti-vascular agents
- Any previous abdominal or pelvic radiotherapy
- Patients with other invasive malignancies within the last 5 years
- Serious uncontrolled medical conditions that, in the opinion of the investigator, would compromise the subject 's ability to receive treatment with the study protocol, such as concurrent serious medical conditions, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.
- Receipt of other experimental agents or participation in another clinical study for anticancer therapeutic purposes within 30 days of first dose
- Serious infection occurred within 4 weeks before the start of study treatment, including but not limited to infectious complications requiring hospitalization, bacteremia or severe pneumonia
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- Patients who are known to be human immunodeficiency virus (HIV) positive
- Patients who are hepatitis B surface antigen positive (HBsAg), and whose peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) titer is ≥ 1 ×103IU/mL; if HBsAg is positive, and peripheral blood HBV-DNA is < 1 ×103 IU/mL, the subject is eligible if the investigator believes that the subject has stable chronic hepatitis B and will not increase the risk of the subject;
- Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive, and HCV RNA test positive
- Patients judged unsuitable for this study by the investigator
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Controlled Clinical Study of Envafolimab (PD-L1 Antibody) Subcutaneous Injection Combined With Endostar and Concurrent Chemoradiotherapy in Treatment of Locally Advanced Primary Cervical Cancer
The goal of this study is to determine efficacy and safety of envafolimab combined with Endostar and concurrent chemoradiation in the treatment of locally advanced primary cervical cancer.
Thirty participants will be divided into control group (n = 15) and experimental group (n = 15). The control group received concurrent chemoradiation, and the experimental group received envafolimab combined with endostar and concurrent chemoradiation.
Read the detailed description
This study was a single-center, prospective cohort study. Thirty Participants will be non-randomized in a 1:1 ratio divided into control group (n = 15) and experimental group (n = 15).
The control group: chemoradiation;
The experimental group: envafolimab combined with endostar and concurrent chemoradiation.
Concurrent chemoradiation:
Cisplatin 40 mg/m2, day1, 7 days as a cycle, 6 cycles in total; External beam radiotherapy was performed using IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45-50.4 Gy;1.8-2.0 Gy/f,25- 28 f. In patients with pelvic lymph node metastasis, para-aortic lymph node metastasis, and retroperitoneal lymph node metastasis, local lesions were simultaneously boosted to 60 Gy. In FIGO stage IIIB, simultaneous or late course boost to 60 Gy was given parametrially.
Brachytherapy: High dose rate (HDR) afterloading brachytherapy was used, with a total dose of 30-40 Gy and a cumulative dose of 80-85 Gy at point A/HRCTV D90; if the tumor diameter was ≥ 4cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90. Brachytherapy combined with external beam radiation therapy was completed within 8 weeks.
Envafulimab,150mg, subcutaneous, QW. Maintenance therapy until disease progression, or intolerable toxicity, or up to 1 year; Endostar, administered at a dose of 75 mg/day, QW, was administered by intravenous pump on day 1 of each cycle, and the first dose was administered on the first day of radiotherapy, 6 cycles in total.
- Conditions
- Cervical Cancer
- Being tested
- cis-platinum, radiation, Envafolimab Injection, Recombinant Human Endostatin Injection
- 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.
cis-platinumDrug
Also called Cisplatin
chemotherapeutics
radiationRadiation
Also called External beam radiotherapy, Brachytherapy
External beam radiotherapy was performed using IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45-50.4 Gy;1.8-2.0 Gy/f,25 -28 f. In patients with pelvic lymph node metastasis, para-aortic lymph node metastasis, and retroperitoneal lymph node metastasis, local lesions were simultaneously boosted to 60 Gy. In FIGO stage IIIB, simultaneous or late course boost to 60 Gy was given parametrially.
Brachytherapy: High dose rate (HDR) afterloading brachytherapy was used, with a total dose of 30-40 Gy and a cumulative dose of 80-85 Gy at point A/HRCTV D90; if the tumor diameter was ≥ 4 cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90. Brachytherapy combined with external beam radiation therapy was completed within 8 weeks.
Envafolimab InjectionDrug
Also called KN035
PD-L1 antibody
Recombinant Human Endostatin InjectionDrug
Also called endostar
angiogenesis inhibitors
| Study group | Role | What they receive |
|---|---|---|
| envafolimab combined with endostar and concurrent chemoradiotherapy | Concurrent Chemoradiation； Envafulimab,150mg, subcutaneous, QW. Maintenance therapy until disease progression, or intolerable toxicity, or up to 1 year; Endostar, administered at a dose of 75 mg/day, QW, was administered by intravenous pump on day 1 of each cycle, and the first dose was administered on the first day of radiotherapy, 6 cycles in total. Receives: Drug: cis-platinum; Radiation: radiation; Drug: Envafolimab Injection; Drug: Recombinant Human Endostatin Injection | |
| concurrent chemoradiotherapy | Concurrent Chemoradiation:
Cisplatin 40 mg/m2, day1, 7 days as a cycle, 6 cycles in total; External beam radiotherapy was performed using IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45-50.4 Gy;1.8-2.0 Gy/f,25- 28 f. In patients with pelvic lymph node metastasis, para-aortic lymph node metastasis, and retroperitoneal lymph node metastasis, local lesions were simultaneously boosted to 60 Gy. In FIGO stage IIIB, simultaneous or late course boost to 60 Gy was given parametrially.
Brachytherapy: High dose rate (HDR) afterloading brachytherapy was used, with a total dose of 30-40 Gy and a cumulative dose of 80-85 Gy at point A/HRCTV D90; if the tumor diameter was ≥ 4cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90. Brachytherapy combined with external beam radiation therapy was completed within 8 weeks. Receives: Drug: cis-platinum; Radiation: radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
ORR was assessed by the site Investigator using RECIST 1.1 and was defined as the percentage of patients with a confirmed overall response of CR or PR.
Measured: From Baseline to 2 years
Secondary outcomes (4)
Disease control rate
DCR was assessed by the site Investigator using RECIST 1.1 and was defined as the percentage of patients with a confirmed overall response of CR or PR or SD.
Measured: From Baseline to 2 years
progression-free survival
the time of all participants from the start of the treatment to tumor progression
Measured: From Baseline to 2 years
overall survival
the time from the start of the treatment to the death of any cause.
Measured: From Baseline to 2 years
The adverse events according to NCI-CTCAE v5.0
Safety (according to NCI-CTCAE v5.0)
Measured: From the start of treatment until 30 days after the last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start16 May 2023 (estimated)
- Primary completion16 May 2024 (estimated)
- Study completion16 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping Jiang, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879796
- Sponsor's protocol ID
- M2023108
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Clinical Study of Envafolimab (PD-L1 Antibody) Subcutaneous Injection Combined With Endostar and Concurrent Chemoradiotherapy in Treatment of Locally Advanced Primary Cervical Cancer
- ClinicalTrials.gov ID
- NCT05879796
- Acronym / sponsor ID
- M2023108
- Conditions
- Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 16 May 2023 (estimated)
- Primary completion
- 16 May 2024 (estimated)
- Study completion
- 16 May 2026 (estimated)
- First posted
- 30 May 2023 (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.
The goal of this study is to determine efficacy and safety of envafolimab combined with Endostar and concurrent chemoradiation in the treatment of locally advanced primary cervical cancer.
Thirty participants will be divided into control group (n = 15) and experimental group (n = 15). The control group received concurrent chemoradiation, and the experimental group received envafolimab combined with endostar and concurrent chemoradiation.
Detailed description
This study was a single-center, prospective cohort study. Thirty Participants will be non-randomized in a 1:1 ratio divided into control group (n = 15) and experimental group (n = 15).
The control group: chemoradiation;
The experimental group: envafolimab combined with endostar and concurrent chemoradiation.
Concurrent chemoradiation:
Cisplatin 40 mg/m2, day1, 7 days as a cycle, 6 cycles in total; External beam radiotherapy was performed using IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45-50.4 Gy;1.8-2.0 Gy/f,25- 28 f. In patients with pelvic lymph node metastasis, para-aortic lymph node metastasis, and retroperitoneal lymph node metastasis, local lesions were simultaneously boosted to 60 Gy. In FIGO stage IIIB, simultaneous or late course boost to 60 Gy was given parametrially.
Brachytherapy: High dose rate (HDR) afterloading brachytherapy was used, with a total dose of 30-40 Gy and a cumulative dose of 80-85 Gy at point A/HRCTV D90; if the tumor diameter was ≥ 4cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90. Brachytherapy combined with external beam radiation therapy was completed within 8 weeks.
Envafulimab,150mg, subcutaneous, QW. Maintenance therapy until disease progression, or intolerable toxicity, or up to 1 year; Endostar, administered at a dose of 75 mg/day, QW, was administered by intravenous pump on day 1 of each cycle, and the first dose was administered on the first day of radiotherapy, 6 cycles in total.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| envafolimab combined with endostar and concurrent chemoradiotherapy | – | Drug: cis-platinum, Radiation: radiation, Drug: Envafolimab Injection, Drug: Recombinant Human Endostatin InjectionConcurrent Chemoradiation； Envafulimab,150mg, subcutaneous, QW. Maintenance therapy until disease progression, or intolerable toxicity, or up to 1 year; Endostar, administered at a dose of 75 mg/day, QW, was administered by intravenous pump on day 1 of each cycle, and the first dose was administered on the first day of radiotherapy, 6 cycles in total. |
| concurrent chemoradiotherapy | – | Drug: cis-platinum, Radiation: radiationConcurrent Chemoradiation: Cisplatin 40 mg/m2, day1, 7 days as a cycle, 6 cycles in total; External beam radiotherapy was performed using IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45-50.4 Gy;1.8-2.0 Gy/f,25- 28 f. In patients with pelvic lymph node metastasis, para-aortic lymph node metastasis, and retroperitoneal lymph node metastasis, local lesions were simultaneously boosted to 60 Gy. In FIGO stage IIIB, simultaneous or late course boost to 60 Gy was given parametrially. Brachytherapy: High dose rate (HDR) afterloading brachytherapy was used, with a total dose of 30-40 Gy and a cumulative dose of 80-85 Gy at point A/HRCTV D90; if the tumor diameter was ≥ 4cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90. Brachytherapy combined with external beam radiation therapy was completed within 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be selected with the help of oncologists in Peking university third hospital. All participants are advanced cervical cancer.
Key inclusion criteria (10 listed)
- Patients with histologically confirmed advanced cervical cancer， FIGO 2018 clinical stages IB3/IIA2 with positive para-aortic lymph nodes 、IIB-IVA disease, patients with locally advanced cervical cancer who are judged by their physician to be eligible for concurrent chemoradiotherapy in this trial, and have not received treatment before enrollment;
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Expected life > 3 months
- LVEF≥55%
Key exclusion criteria (10 listed)
- Prior treatment with an anti-PD-1, anti-PD-L1 or anti-vascular agents
- Any previous abdominal or pelvic radiotherapy
- Patients with other invasive malignancies within the last 5 years
- Serious uncontrolled medical conditions that, in the opinion of the investigator, would compromise the subject 's ability to receive treatment with the study protocol, such as concurrent serious medical conditions, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.
- Receipt of other experimental agents or participation in another clinical study for anticancer therapeutic purposes within 30 days of first dose
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 |
|---|---|---|
| cis-platinumAlso: Cisplatinchemotherapeutics | Drug | concurrent chemoradiotherapy, envafolimab combined with endostar and concurrent chemoradiotherapy |
| radiationAlso: External beam radiotherapy, BrachytherapyExternal beam radiotherapy was performed using IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45-50.4 Gy;1.8-2.0 Gy/f,25 -28 f. In patients with pelvic lymph node metastasis, para-aortic lymph node metastasis, and retroperitoneal lymph node metastasis, local lesions were simultaneously boosted to 60 Gy. In FIGO stage IIIB, simultaneous or late course boost to 60 Gy was given parametrially. Brachytherapy: High dose rate (HDR) afterloading brachytherapy was used, with a total dose of 30-40 Gy and a cumulative dose of 80-85 Gy at point A/HRCTV D90; if the tumor diameter was ≥ 4 cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90. Brachytherapy combined with external beam radiation therapy was completed within 8 weeks. | Radiation | concurrent chemoradiotherapy, envafolimab combined with endostar and concurrent chemoradiotherapy |
| Envafolimab InjectionAlso: KN035PD-L1 antibody | Drug | envafolimab combined with endostar and concurrent chemoradiotherapy |
| Recombinant Human Endostatin InjectionAlso: endostarangiogenesis inhibitors | Drug | envafolimab combined with endostar and concurrent chemoradiotherapy |
Primary outcome
Objective response rate
Time frame: From Baseline to 2 years
ORR was assessed by the site Investigator using RECIST 1.1 and was defined as the percentage of patients with a confirmed overall response of CR or PR.
4 secondary outcomes
Disease control rate
Time frame: From Baseline to 2 years
progression-free survival
Time frame: From Baseline to 2 years
overall survival
Time frame: From Baseline to 2 years
The adverse events according to NCI-CTCAE v5.0
Time frame: From the start of treatment until 30 days after the last study drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- 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.
Ping Jiang, MD principal investigator
Study Principal Investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by Peking University Third Hospital.
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 10 inclusion and 10 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 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Ping Jiang, MD (13439796018, drjiangping@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: From Baseline to 2 years). 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 30 May 2023.