Clinical trial NCT04368273: Pd-1 Antibody Combined CCRT for Local Advanced Cervical Cancer.
Official title: Phase I Study of Toripalimab Injection (Pd-1 Antibody) With Cisplatin Concurrent IMRT for Local Advanced Cervical Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cervical Cancer
Keywords: PD-1
Radiotherapy
concurrent chemoradiotherapy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence and severity of acute adverse events
timeFrame: up to 3 months complete treatment
Secondary outcomes:
measure: Objective response rate
timeFrame: 3 months later after treatment
measure: Progression-free survival
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University 3rd Hospital
state: Beijng
Study officials:
affiliation: Peking University 3rd Hospital radiation oncology department
name: Junjie Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: