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

NCT ID: NCT04884906

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2024-11-01

Brief Summary

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

Detailed 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.

Conditions

Locally Advanced Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab combined with radiotherapy and chemotherapy

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: BIOLOGICAL

200mg/m2, iv, d1, Q3W, a total of 6 cycles

radiotherapy

Intervention Type: RADIATION

1.8-2.15Gy/time (radiotherapy started on the 8th day of camrelizumab treatment), a total of 28 times (5 times a week), a total of 50.4-60.2Gy.

Albumin Paclitaxel

Intervention Type: DRUG

260mg/m2, iv, d1, Q3W, a total of 6 cycles

Cisplatin

Intervention Type: DRUG

80-120mg/m2, iv, d1-3, Q3W, a total of 6 cycles

Interventions

Camrelizumab

200mg/m2, iv, d1, Q3W, a total of 6 cycles

Intervention Type: BIOLOGICAL

radiotherapy

1.8-2.15Gy/time (radiotherapy started on the 8th day of camrelizumab treatment), a total of 28 times (5 times a week), a total of 50.4-60.2Gy.

Intervention Type: RADIATION

Albumin Paclitaxel

260mg/m2, iv, d1, Q3W, a total of 6 cycles

Intervention Type: DRUG

Cisplatin

80-120mg/m2, iv, d1-3, Q3W, a total of 6 cycles

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years old and ≤75 years old;

2. ECOG score 0-1 level;

3. Cervical cancer diagnosed pathologically, cervical cancer that has recurred or metastasized after at least first-line chemotherapy or surgery;

4. Genetic testing: PD-L1≥1%;

5. The expected survival period is ≥6 months;

6. The functional level of major organs must meet the following requirements:

Blood routine: ANC≥1.5×109/L; PLT≥90×109/L; Hb≥90 g/L; Blood biochemistry: TBIL≤2.5×ULN; ALT and AST≤1.5×ULN; BUN and Cr ≤1.5×ULN;

7. Heart color Doppler ultrasound: LVEF≥50%;

8. 12-lead electrocardiogram: QT interval (QTcF) corrected by Fridericia method <450 ms for males and <470 ms for females;

9. No blood transfusion within 2 weeks before screening;

10. 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;

11. Volunteer to join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up.

Exclusion Criteria

1. 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;

2. 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;

3. At the same time receive anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;

4. 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.

5. Those who are known to have a history of allergies to the drug components of this program;

6. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.

7. 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.

8. 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.

9. 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;

10. Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect the administration and absorption of drugs.

11. The researcher believes that the subject is not suitable for participating in any other situations in this research.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

TianjinCIH

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen

Role: CONTACT

Facility Contacts

Chen Zhongjie

Role: primary

13702096685@139.com

18622228638

Other Identifiers

E20210044

Identifier Type: -

Identifier Source: org_study_id