Status:
UNKNOWN
Pd-1 Antibody Combined CCRT for Local Advanced Cervical Cancer.
Lead Sponsor:
Peking University Third Hospital
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
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; Rad...
Eligibility Criteria
Inclusion
- HPV positive in patients with cervical squamous cell carcinoma confirmed by histopathology
- Patients with local advanced (2018FIGO staged IB3, IIA -IVA) cervical cancer and had not received any treatment before
- There are measurable lesions according to the efficacy evaluation criteria for solid tumors (RECIST) version 1.1
- ECOG score 0-2
- Expected survival ≥3 months
- LVEF≥55%
- Bone marrow function: neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥90g/L
- 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
- Thyroid function: normal range
- Non-lactating patients
- Sign the informed consent
Exclusion
- Patients with previous PD-1 or PD-L1 treatment
- Patients with previous abdominal or pelvic radiotherapy
- Other malignant tumors other than cervical cancer appeared in the past 5 years
- 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)
- 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.)
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
- Known allergy to any component of the drug
- 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
- Received other experimental drugs or participated in other drugs within 30 days of initial administration clinical research on the purpose of anticancer therapy
- 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
- Human immunodeficiency virus (HIV) positive
- 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
- Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) Antibody positive and HCV RNA positive
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04368273
Start Date
May 8 2020
End Date
December 31 2022
Last Update
April 29 2020
Active Locations (1)
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1
Peking University 3rd Hospital
Beijing, Beijng, China, 100191