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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-PD-1 | Experimental | PD-1+albumin-bound paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival(PFS) | Progression-free survival was defined as the duration of time from study entry to time of progression, death, or the date of last contact, whichever occurs first. | up to 2 years |
| Overall Survival(OS) |
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Inclusion Criteria:
Exclusion Criteria:
female
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38106561 | Derived | 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. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
| up to 2 years |
| Disease Control Rate(DCR) | Disease control rate was defined as the proportion of subjects with complete response (CR) or partial response (PR) or disease stabilization (SD) in the analyzed population according to the RECIST 1.1 criteria. | up to 2 years |
| Duration of Response(DoR) | Duration of response was defined as the time when the tumor is first evaluated as CR or PR to the first assessment for progressive disease(PD) or for any cause of death. | up to 2 years |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |