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A single-arm, single-center, open, prospective phase II clinical study of carrelizumab 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 carrelizumab combined with radiotherapy and chemotherapy for the treatment of recurrent or metastatic cervical cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041564
Enrollment
Unknown
Registered
2020-12-29
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer

Interventions

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 and = 1%; 5. Estimated survival time >= 6 months; 6. The functional level of major organs must meet the following requirements: Blood routine: ANC >= 1.5 x 10^9/L; PLT >= 90 x 10^9/L; Hb >= 90 g/L; Blood biochemistry: TBIL = 50%; 8. 12 Lead ECG: 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, agree to abstain from sex or use an effective method of contraception during the treatment period and at least 7 months after the last dose in the study treatment; 11. Volunteer to join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. Have received previous anti-tumor treatment 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 treated with Carrelizumab 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 known to be against any Carrelizumab, or tested Patients are allergic to the components of chemotherapy used during neoadjuvant treatment; 3. At the same time receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy; 4. Have received major surgical operations not related to cervical cancer within 4 weeks before randomization, 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. Has ever suffered from any heart disease, including: (1) angina pectoris; (2) arrhythmia requiring medication 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 test period. 9. According to the judgment of the investigator, there are accompanying diseases (including but not limited to hypertension, 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 investigator believes that the subject is not suitable for participating in any other situations in this study.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Countries

China

Contacts

Public ContactChen Zhongjie

Tianjin Medical University Cancer Institute and Hospital

13702096685@139.com+86 18622228638

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026