Envafolimab Combined With Endostar and Concurrent Chemoradiotherapy for Locally Advanced Primary Cervical Cancer

NCT05879796 | Not Yet Recruiting

• 1 other identifier: M2023108
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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). The control group received concurrent chemoradiation, and the experimental group received envafolimab combined with endostar and concurrent chemoradiation.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  From Baseline to 2 years

Secondary Outcomes (4)

• Disease control rate

  From Baseline to 2 years

• progression-free survival

  From Baseline to 2 years

• overall survival

  From Baseline to 2 years

• The adverse events according to NCI-CTCAE v5.0

  From the start of treatment until 30 days after the last study drug administration

Study Arms (2)

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.

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.

Drug: cis-platinum; Radiation: radiation

Interventions

cis-platinum DRUG

chemotherapeutics

Also known as: Cisplatin

concurrent chemoradiotherapy; envafolimab combined with endostar and concurrent chemoradiotherapy

radiation RADIATION

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.

Also known as: External beam radiotherapy, Brachytherapy

concurrent chemoradiotherapy; envafolimab combined with endostar and concurrent chemoradiotherapy

Envafolimab Injection DRUG

PD-L1 antibody

Also known as: KN035

envafolimab combined with endostar and concurrent chemoradiotherapy

Recombinant Human Endostatin Injection DRUG

angiogenesis inhibitors

Also known as: endostar

envafolimab combined with endostar and concurrent chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be selected with the help of oncologists in Peking university third hospital. All participants are advanced cervical cancer.

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Radiation; Brachytherapy; envafolimab; Endostatins; endostar protein

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena; Radiotherapy; Therapeutics; Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• Ping Jiang, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Jiang, MD

CONTACT

13439796018; drjiangping@qq.com

Junjie Wang, MD, PhD

CONTACT

13701076310; junjiewang_edu@sina.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 30, 2023
• Study Start: May 16, 2023
• Primary Completion: May 16, 2024
• Study Completion (Estimated): May 16, 2026
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share