Clinical trial · Interventional
Study of Anti-PD-1 Combined With Albumin-Bound Paclitaxel in Patients With Recurrent Cervical Cancer
A Open-label, Single-arm, Multicentre, Phase Ⅱ Study of Evaluate Efficacy and Safety of Anti-PD-1 Combined With Albumin-Bound Paclitaxel in Patients With Recurrent Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-PD-1+Albumin-Bound Paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-PD-1
- description
- PD-1+albumin-bound paclitaxel
- interventionNames
- Drug: anti-PD-1+Albumin-Bound Paclitaxel
Primary outcomes (1)
- measure
- Objective Response Rate(ORR)
- timeFrame
- up to 2 years
- description
- 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.
Secondary outcomes (4)
- measure
- Progression Free Survival(PFS)
- timeFrame
- up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWang 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