Study of Anti-PD-1 Combined With Albumin-Bound Paclitaxel in Patients With Recurrent Cervical Cancer

NCT ID: NCT04341883

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-13
• Study Completion Date: 2023-12-31

Brief Summary

This is an open-label, single-arm, phase II, multi-center clinical trial. Subjects can only enter this study after they meet the inclusion and exclusion criteria. All enrolled patients will receive the treatment with anti-PD-1 combined with albumin-bound paclitaxel, every 3 weeks, until progressive disease, initiation of new anti-tumour therapy, death, intolerable toxicity. Albumin-bound paclitaxel may be used for up to 6 cycles and anti-PD-1 for up to 2 years.

Conditions

Recurrent Cervical Cancer

Study Design

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

Study Groups

anti-PD-1

PD-1+albumin-bound paclitaxel

Group Type: EXPERIMENTAL

anti-PD-1+Albumin-Bound Paclitaxel

Intervention Type: DRUG

anti-PD-1: 200mg/3w+Albumin-bound paclitaxel: 260 mg/m2/3w.Albumin-bound paclitaxel may be used for up to 6 cycles, and anti-PD-1 for up to 2 years.

Other Name: Programmed cell death 1 antibody

Interventions

anti-PD-1+Albumin-Bound Paclitaxel

anti-PD-1: 200mg/3w+Albumin-bound paclitaxel: 260 mg/m2/3w.Albumin-bound paclitaxel may be used for up to 6 cycles, and anti-PD-1 for up to 2 years.

Other Name: Programmed cell death 1 antibody

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntarily participate and have signed the informed consent form (ICF);

2. Patients histologically diagnosed with cervical cancer ;

3. Patients with advanced cervical cancer who have experienced progressive disease or relapse after receiving standard treatment (first-line chemotherapy must be included) or who are intolerant to first-line chemotherapy.

4. The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1;

5. An Eastern Cooperative Oncology Group(ECOG) score of 0 or 1;

6. Life expectancy ≥ 3 months;

7. Adequate hepatic, renal, heart, and hematologic functions. Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 70×109/L, Hemoglobin(HGB) ≥ 80 g/L, total bilirubin within 1.5×the upper limit of normal (ULN), and serum transaminase≤2.5×Upper Limit Of Normal(ULN), serum creatine ≤ 1.5 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥50ml/min, International Normalized Ratio<1.5 x Upper Limit Of Normal(ULN), Urinary protein≤（+）and Thyroid stimulating hormone≤ 1.5 x Upper Limit Of Normal(ULN).

Exclusion Criteria

1. Pathology confirmed with sarcoma components (including malignant mixed mullerian tumors, endometrial leiomyosarcoma, and endometrial stromal sarcoma);

2. Patients who have previously received albumin-bound paclitaxel or exposures to any anti-PD-1 antibody drugs;

3. Exposures to any anti-tumor drugs within 4 weeks;

4. Current or prior use of any immunosuppressive medication or systemic hormone therapy（which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid Prednisone>10mg/d）within 14 days before the first dose of anti-PD-1 antibody;

5. Any primary malignancy within 5 years (except for fully treated in situ malignant such as breast cancer, bladder cancer, cervical carcinoma in situ, cutaneous basal cell carcinoma or squamous cell carcinoma);

6. History of psychiatric drugs abuse and not be abstinent, or dysphrenia；

7. Central nervous system diseases, including uncontrollable epilepsy and symptomatic brain metastases;

8. Severe cardiovascular disease: unstable angina pectoris, myocardial infarction, grade III-IV cardiac insufficiency (NYHA standard), and peripheral vascular disease above 2 degrees within 6 months prior to enrollment;

9. Severe arrhythmia requiring drug control, QT interval >470ms；

10. Active infections such as HIV/AIDS or other serious infectious diseases;

11. Any active autoimmune disease or history of autoimmune disease (including but not limit to autoimmune hepatitis, interstitial pneumonia, hepatitis, enteritis, nephritis, hyperthyroidism, pituitary inflammation, vasculitis, uveitis) . Patients need receiving systemic hormonal therapy and/or immunosuppressive therapy (eg asthma requiring bronchodilators);

12. Receipt of live attenuated vaccination within 30 days prior to study entry;

13. Other conditions regimented at investigators' discretion.

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

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xin Huang

Hospital Chief Physician，Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

References

Wang Y, Zhao J, Liang H, Liu J, Huang S, Zou G, Huang X, Lan C. Efficacy and safety of sintilimab plus albumin-bound-paclitaxel in recurrent or metastatic cervical cancer: a multicenter, open-label, single-arm, phase II trial. EClinicalMedicine. 2023 Oct 24;65:102274. doi: 10.1016/j.eclinm.2023.102274. eCollection 2023 Nov.

Reference Type: DERIVED

PMID: 38106561 (View on PubMed)

Other Identifiers

B2019-204-01

Identifier Type: -

Identifier Source: org_study_id