Pd-1 Antibody Combined CCRT for Local Advanced Cervical Cancer. (CCRT+PD-1)

Peking University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Cervical Cancer

Treatments

Drug: PD-1 antibody

Study type

Interventional

Funder types

Other

Identifiers

NCT04368273

M2019482

Details and patient eligibility

About

To evaluate the safety and efficacy of anti-PD-1 (toripalimab) combined with cisplatin concurrent IMRT for locally advanced cervical cancer.

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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