Pd-1 Antibody Combined CCRT for Local Advanced Cervical Cancer.

Cervical Cancer Clinical Trial

— CCRT+PD-1  

Official title:

Phase I Study of Toripalimab Injection (Pd-1 Antibody) With Cisplatin Concurrent IMRT for Local Advanced Cervical Cancer.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04368273
• Other study ID #: M2019482
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: May 8, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2020
• Source: Peking University Third Hospital
• Contact: Ping Jiang, MD
• Phone: 010-82266699
• Email: drjiangping[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• PD-1 antibody
a new treatment drug combined radical radiotherapy concurrent chemotharpy

Locations

Country	Name	City	State
China	Peking University 3rd Hospital	Beijing	Beijng

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of acute adverse events	safety evaluation	up to 3 months complete treatment
Secondary	Objective response rate	efficacy evaluation	3 months later after treatment
Secondary	Progression-free survival	efficacy evaluation	up to 2 years