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

A Single-arm, Single-center, Open, Prospective Phase II Clinical Study of Camrelizumab Combined With Radiotherapy and Chemotherapy for the Treatment of Recurrent or Metastatic Cervical Cancer

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

Study Overview

• Status: Recruiting
• Conditions: Locally Advanced Cervical Cancer
• Intervention / Treatment: Biological: Camrelizumab; Radiation: radiotherapy; Drug: Albumin Paclitaxel; Drug: Cisplatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chen

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • TianjinCIH
      • Contact: Chen Zhongjie; Phone Number: 18622228638; Email: 13702096685@139.com

Participation Criteria

Eligibility Criteria

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

Description

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.

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: Camrelizumab combined with radiotherapy and chemotherapy	Biological: Camrelizumab; 200mg/m2, iv, d1, Q3W, a total of 6 cycles; Radiation: 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.; Drug: Albumin Paclitaxel; 260mg/m2, iv, d1, Q3W, a total of 6 cycles; Drug: Cisplatin; 80-120mg/m2, iv, d1-3, Q3W, a total of 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	The objective remission rate refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission and partial remission	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival（PFS）	The period of time between when a patient with neoplastic disease receives treatment and when the disease progresses or death from any cause occurs	2 year
Overall survival（OS）	The time from the patient's confirmation of the disease to death due to any cause	2 year
Disease control rate（DCR）	Refers to the proportion of patients whose tumors have shrunk or stabilized for a certain period of time, including complete remission (CR), partial remission (PR) and stable (SD) cases	2 year
Adverse reaction rate	Harmful and unrelated reactions that occur when normal doses of drugs are used to prevent, diagnose, treat diseases or regulate physiological functions	2 year
Patient quality of life	Comprehensively evaluate the pros and cons of life by filling in the questionnaire	2 year

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Cisplatin
• Other Study ID Numbers: E20210044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No