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

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

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

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: PD-1 antibody

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijng
    • Beijing, Beijng, China, 100191
      • Peking University 3rd Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; PD-1 antibody combined CCRT for patients with local advanced cervical cancer.	Drug: PD-1 antibody; a new treatment drug combined radical radiotherapy concurrent chemotharpy; Other Names: Toripalimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of acute adverse events	safety evaluation	up to 3 months complete treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	efficacy evaluation	3 months later after treatment
Progression-free survival	efficacy evaluation	up to 2 years

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Junjie Wang, MD, Peking University 3rd Hospital radiation oncology department

Study record dates

Study Major Dates

• Study Start (Anticipated): May 8, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 25, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Radiotherapy; PD-1; concurrent chemoradiotherapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: M2019482

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No