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

NCT04341883 | Completed Phase 2

• 1 other identifier: B2019-204-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  Objective tumor response was defined as the proportion of patients whose tumor volume has been reduced to a predetermined value and can be maintained for more than 4 weeks, ie ORR=CR+PR.

  up to 2 years

Secondary Outcomes (4)

• Progression Free Survival(PFS)

  up to 2 years

• Overall Survival(OS)

  up to 2 years

• Disease Control Rate(DCR)

  up to 2 years

• Duration of Response(DoR)

  up to 2 years

Study Arms (1)

anti-PD-1

EXPERIMENTAL

PD-1+albumin-bound paclitaxel

Drug: anti-PD-1+Albumin-Bound Paclitaxel

Interventions

anti-PD-1+Albumin-Bound Paclitaxel 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

anti-PD-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate and have signed the informed consent form (ICF);
• Patients histologically diagnosed with cervical cancer ;
• 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.
• The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1;
• An Eastern Cooperative Oncology Group(ECOG) score of 0 or 1;
• Life expectancy ≥ 3 months;
• 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).

You may not qualify if:

• Pathology confirmed with sarcoma components (including malignant mixed mullerian tumors, endometrial leiomyosarcoma, and endometrial stromal sarcoma);
• Patients who have previously received albumin-bound paclitaxel or exposures to any anti-PD-1 antibody drugs;
• Exposures to any anti-tumor drugs within 4 weeks;
• 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;
• 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);
• History of psychiatric drugs abuse and not be abstinent, or dysphrenia；
• Central nervous system diseases, including uncontrollable epilepsy and symptomatic brain metastases;
• 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;
• Severe arrhythmia requiring drug control, QT interval \>470ms；
• Active infections such as HIV/AIDS or other serious infectious diseases;
• 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);
• Receipt of live attenuated vaccination within 30 days prior to study entry;
• Other conditions regimented at investigators' discretion.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• 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.

  PMID: 38106561 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital Chief Physician，Professor

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 10, 2020
• Study Start: January 13, 2020
• Primary Completion: May 22, 2022
• Study Completion: April 26, 2024
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

CN (1)