Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04884906
Other study ID # E20210044
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 1, 2020
Est. completion date November 1, 2024

Study information

Verified date May 2021
Source Tianjin Medical University Cancer Institute and Hospital
Contact Chen
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date November 1, 2024
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
China TianjinCIH Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Overall survival(OS) The time from the patient's confirmation of the disease to death due to any cause 2 year
Secondary 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
Secondary 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
Secondary Patient quality of life Comprehensively evaluate the pros and cons of life by filling in the questionnaire 2 year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03225443 - Observation and Evaluation of Short-term Curative Effect of Local Advanced Cervical Cancer Treated With Particle Radiotherapy Versus Neoadjuvant Chemotherapy N/A
Recruiting NCT06079671 - Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical) Phase 3
Completed NCT05059119 - Rectovaginal Fistula in Post-Radiotherapy Advanced Cervical Cancer Patients
Recruiting NCT06055738 - Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of LACC Phase 2
Recruiting NCT06156514 - Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer Phase 3
Completed NCT03298893 - Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months Phase 1/Phase 2
Withdrawn NCT01514955 - An Initial Feasibility Study to Integrate MRI Based Brachytherapy and CT/MR Fused INRT in Treatment of Advance Cervical Cancer Phase 1
Recruiting NCT05950087 - Study on the Relationship Between Plasma MRD and cfDNA HPV and the Efficacy and Prognosis of Locally Advanced Cervical Cancer After Concurrent Chemoradiotherapy
Not yet recruiting NCT05799469 - Study of Chemoradiotherapy With Envafolimab For The Treatment of Locally Advanced Cervical Cancer Phase 2
Recruiting NCT05311566 - PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer Phase 2
Terminated NCT02045433 - Stereotactic Body Radiation Therapy (SABR) for Definitive Treatment of Locally Advanced Cervical Cancer Phase 2
Recruiting NCT06237257 - A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer Phase 2
Not yet recruiting NCT06288360 - Neoadjuvant Immunochemotherapy in PD-L1-negative LACC Phase 2
Not yet recruiting NCT06288373 - Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC Phase 2/Phase 3
Recruiting NCT06068387 - A Prospective Study on the Prediction Model of Para-aortic Lymph Node Metastasis N/A
Recruiting NCT05378087 - Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer N/A
Recruiting NCT03963882 - NAC Followed by RH for the Treatment of LACC Phase 2
Recruiting NCT01938105 - Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer Phase 2
Active, not recruiting NCT01793701 - Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer Phase 1/Phase 2
Completed NCT01230996 - Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer Phase 1/Phase 2