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This is a single-arm, open-label, multicentre, phase II clinical study.Subjects can only enter this study after they meet the inclusion and exclusion criteria.All enrolled patients will receive the treatment with HLX10 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 HLX10 for up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLX10 | Experimental | HLX10+albumin-bound paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX10+Albumin-Bound Paclitaxel | Drug | HLX10: 4.5 mg/kg/3w+Albumin-bound paclitaxel: 260 mg/m2/3w.Albumin-bound paclitaxel may be used for up to 6 cycles, and HLX10 for up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1) | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (ORR) (assessed by IRRC as per iRECIST, and by the investigator as per RECIST v1.1 and iRECIST, respectively) | up to 2 years |
| PFS | Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 and iRECIST, respectively) |
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Inclusion Criteria:
Voluntarily participate and have signed the informed consent form (ICF);
Aged ℠18 years and ⤠75 years at the time of signing the ICF
Patients histologically or cytologically diagnosed with cervical cancer (pathology report is required and pathological types are cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma).
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. First-line chemotherapy includes any of the following:
The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1(IRRC).
Patients whose tumour specimens are tested positive for PD-L1 expression (CPS ā„ 1).
An ECOG score of 0 or 1.
Conforming to laboratory measurements;
Exclusion Criteria:
8.With human immunodeficiency virus (HIV) infection. 9.With active pulmonary tuberculosis. 10.Have received any T-cell costimulatory or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other agents that target T cells.
female
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| Name | Affiliation | Role |
|---|---|---|
| lingying wu | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37153587 | Derived | An J, Li X, Wang J, Zhu L, An R, Jiang K, Huang Y, Wang K, Li G, Wang C, Yuan J, Hou X, Yang G, Li J, Wang Q, Zhu J, Wu L. Efficacy and safety of serplulimab plus nab-paclitaxel in previously treated patients with PD-L1-positive advanced cervical cancer: a phase II, single-arm study. Front Immunol. 2023 Apr 21;14:1142256. doi: 10.3389/fimmu.2023.1142256. eCollection 2023. |
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|
| from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years |
| 6-month PFS rate | 6-month progression-free survival rate | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 6 months |
| OS | Overall survival | from the date of first dose until the date of death from any causeļ¼assessed up to 2 years |
| 6-month OS rate | 6-month overall survival rate | from the date of first dose until the date of 6-month |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
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