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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368273
Recruitment Status : Not yet recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Junjie Wang, Peking University Third Hospital

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

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: PD-1 antibody Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Toripalimab Injection (Pd-1 Antibody) With Cisplatin Concurrent IMRT for Local Advanced Cervical Cancer.
Estimated Study Start Date : May 8, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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 Name: Toripalimab




Primary Outcome Measures :
  1. Incidence and severity of acute adverse events [ Time Frame: up to 3 months complete treatment ]
    safety evaluation


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 3 months later after treatment ]
    efficacy evaluation

  2. Progression-free survival [ Time Frame: up to 2 years ]
    efficacy evaluation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368273


Contacts
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Contact: Ping Jiang, MD 010-82266699 ext 4912 drjiangping@qq.com

Locations
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China, Beijng
Peking University 3rd Hospital
Beijing, Beijng, China, 100191
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Principal Investigator: Junjie Wang, MD Peking University 3rd Hospital radiation oncology department
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Responsible Party: Junjie Wang, Department director, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04368273    
Other Study ID Numbers: M2019482
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Junjie Wang, Peking University Third Hospital:
PD-1
Radiotherapy
concurrent chemoradiotherapy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs