Camrelizumab Combined With Radiotherapy and Chemotherapy for the Treatment of Recurrent or Metastatic Cervical Cancer

  • STATUS
    Recruiting
  • End date
    Nov 1, 2024
  • participants needed
    40
  • sponsor
    Tianjin Medical University Cancer Institute and Hospital
Updated on 20 May 2021

Summary

To evaluate the effectiveness and safety of camrelizumab combined with radiotherapy and chemotherapy for recurrent or metastatic cervical cancer

Description

This study is a single-arm, single-center, open, prospective phase II clinical study, the main purpose of which is to evaluate the effectiveness and safety of camrelizumab combined with radiotherapy and chemotherapy for recurrent or metastatic cervical cancer.

Details
Condition Locally Advanced Cervical Cancer
Treatment cisplatin, Radiotherapy, Camrelizumab, Albumin Paclitaxel
Clinical Study IdentifierNCT04884906
SponsorTianjin Medical University Cancer Institute and Hospital
Last Modified on20 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years old and 75 years old
ECOG score 0-1 level
Cervical cancer diagnosed pathologically, cervical cancer that has recurred or metastasized after at least first-line chemotherapy or surgery
Genetic testing: PD-L11%
The expected survival period is 6 months
The functional level of major organs must meet the following requirements
Blood routine: ANC1.5109/L; PLT90109/L; Hb90 g/L; Blood biochemistry
TBIL2.5ULN; ALT and AST1.5ULN; BUN and Cr 1.5ULN
\. Heart color Doppler ultrasound: LVEF50%
\. 12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia
method <450 ms for males and <470 ms for females
\. No blood transfusion within 2 weeks before screening
\. For female subjects who have not undergone menopause or have not
undergone surgical sterilization, during the treatment period and at least 7
months after the last administration in the study treatment, agree to abstain
from sex or use an effective method of contraception
\. Volunteer to join the study, sign informed consent, have good compliance
and are willing to cooperate with follow-up

Exclusion Criteria

Have received previous anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors
Previously received camrelizumab or other PD-1/PD-L1 treatments and cannot be included in the group; the subject is known to have been exposed to macromolecular protein preparations, or is known to be against any carrelizumab, or Subjects are allergic to the chemotherapeutic ingredients used during neoadjuvant treatment
At the same time receive anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy
In the 4 weeks before randomization, have received major surgical operations not related to cervical cancer, or the subject has not fully recovered from such surgical operations
Those who are known to have a history of allergies to the drug components of this program
A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation
Have ever suffered from any heart disease, including: (1) angina pectoris; (2) arrhythmia requiring medical treatment or clinical significance; (3) myocardial infarction; (4) heart failure; (5) any investigator Other heart diseases judged to be unsuitable for participating in this test
Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period
According to the judgment of the investigator, there are concomitant diseases (including but not limited to high blood pressure, severe diabetes, active infection, thyroid disease, etc.) that seriously endanger the safety of the patient or affect the completion of the study
Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect the administration and absorption of drugs
The researcher believes that the subject is not suitable for participating in any other situations in this research
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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