Cervical Cancer
Conditions
Keywords
PD-1, Radiotherapy, concurrent chemoradiotherapy
Brief summary
To evaluate the safety and efficacy of anti-PD-1 (toripalimab) combined with cisplatin concurrent IMRT for locally advanced cervical cancer.
Detailed description
The dose of toripalimab injection (pd-1 antibody) was 240mg/d, d1, i.v. every 14d, totally 4 cycles (56 days) Concurrent chemoradiotherapy: Cisplatin 40 mg/m2 i.v., d1, administered once a week; Radiotherapy: pelvic intensity modulated radiotherapy, prescription dose DT: 50.4gy /2Gy/28f;After intraluminal irradiation DT: 30-36 Gy/6Gy/5-6f 2f/w, complete the radiotherapy within 56 days. Complete at least 4 cycles of concurrent chemoradiotherapy.
Interventions
DRUGPD-1 antibody
a new treatment drug combined radical radiotherapy concurrent chemotharpy
Sponsors
Peking University Third Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. HPV positive in patients with cervical squamous cell carcinoma confirmed by histopathology 2. Patients with local advanced (2018FIGO staged IB3, IIA -IVA) cervical cancer and had not received any treatment before 3. There are measurable lesions according to the efficacy evaluation criteria for solid tumors (RECIST) version 1.1 4. ECOG score 0-2 5. Expected survival ≥3 months 6. LVEF≥55% 7. Bone marrow function: neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥90g/L 8. Liver and kidney functions: serum creatinine ≤1.5 times the upper limit of normal value;AST and ALT ≤2.5 times normal upper limit or ≤5 times normal upper limit in the presence of liver metastasis;Total bilirubin ≤1.5 times the upper limit of normal value, or ≤2.5 times the upper limit of normal value in patients with Gilbert's syndrome 9. Thyroid function: normal range 10. Non-lactating patients 11. Sign the informed consent
Exclusion criteria
1. Patients with previous PD-1 or PD-L1 treatment 2. Patients with previous abdominal or pelvic radiotherapy 3. Other malignant tumors other than cervical cancer appeared in the past 5 years 4. Immunosuppressive drugs were used within 4 weeks prior to the first study treatment, excluding nasal spray, inhaled or other local glucocorticoids or systemic glucocorticoids in physiological doses (i.e., no more than 10 mg/ day prednisone or equivalent doses of other glucocorticoids) 5. Active, known, or suspected autoimmune disease (congenital or acquired) ), such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. (vitiligo or childhood asthma has been completely relieved, adults without any intervention can be included;Patients with type 1 diabetes with good insulin control can also be enrolled, as can hypothyroidism caused by autoimmune thyroiditis that requires hormone replacement therapy.) 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation 7. Known allergy to any component of the drug 8. Serious medical diseases that are not under control, such as the combination of serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension,uncontrolled infection, active peptic ulcer 9. Received other experimental drugs or participated in other drugs within 30 days of initial administration clinical research on the purpose of anticancer therapy 10. Severe infection occurred within 4 weeks prior to study treatment, including, but not limited to, hospitalization hospital treatment of infection complications, bacteremia or severe pneumonia 11. Human immunodeficiency virus (HIV) positive 12. Hepatitis B surface antigen (HBsAg) positive, and the peripheral blood hepatitis B virus deoxygenation the titer of ribonucleic acid (HBV-DNA) was detected in subjects ≥1×10\<3\> IU/mL 13. Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) Antibody positive and HCV RNA positive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of acute adverse events | up to 3 months complete treatment | safety evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 3 months later after treatment | efficacy evaluation |
| Progression-free survival | up to 2 years | efficacy evaluation |
Countries
China
Contacts
Primary ContactPing Jiang, MD
Outcome results
None listed