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

NCT04884906 | Unknown Phase 2

• 1 other identifier: E20210044
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Locally Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Progression-free survival（PFS）

  2 year

• Overall survival（OS）

  2 year

• Disease control rate（DCR）

  2 year

• Adverse reaction rate

  2 year

• Patient quality of life

  2 year

Study Arms (1)

Camrelizumab combined with radiotherapy and chemotherapy

EXPERIMENTAL

Biological: Camrelizumab; Radiation: radiotherapy; Drug: Albumin Paclitaxel; Drug: Cisplatin

Interventions

Camrelizumab BIOLOGICAL

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

Camrelizumab combined with radiotherapy and chemotherapy

radiotherapy 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.

Camrelizumab combined with radiotherapy and chemotherapy

Albumin Paclitaxel DRUG

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

Camrelizumab combined with radiotherapy and chemotherapy

Cisplatin DRUG

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

Camrelizumab combined with radiotherapy and chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-L1≥1%;
• The expected survival period is ≥6 months;
• 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;
• Heart color Doppler ultrasound: LVEF≥50%;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

TianjinCIH

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; Radiotherapy; Cisplatin

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Chen

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 13, 2021
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2024
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)