Cervical Cancer
Conditions
Brief summary
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.
Interventions
DRUGHLX10+Albumin-Bound Paclitaxel
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.
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily participate and have signed the informed consent form (ICF); 2. Aged ≥ 18 years and ≤ 75 years at the time of signing the ICF 3. Patients histologically or cytologically diagnosed with cervical cancer (pathology report is required and pathological types are cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma). 4. 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: 1. Platinum-based drugs + taxanes; 2. Platinum-based drugs + topotecan; 3. Taxanes + topotecan. 5. The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1(IRRC). 6. Patients whose tumour specimens are tested positive for PD-L1 expression (CPS ≥ 1). 7. An ECOG score of 0 or 1. 8. Conforming to laboratory measurements;
Exclusion criteria
1. Patients who have previously received albumin-bound paclitaxel. 2. Patients with other active malignancies within 5 years or at the same time. 3. Patients who are preparing for or have received an organ or bone marrow transplant. 4. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 5. Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathological examination. 6. Class III to IV cardiac insufficiency according to NYHA classification or an LVEF (left ventricular ejection fraction) \< 50% by cardiac colour Doppler. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 2 years | Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 2 years | Objective response rate (ORR) (assessed by IRRC as per iRECIST, and by the investigator as per RECIST v1.1 and iRECIST, respectively) |
| PFS | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years | Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 and iRECIST, respectively) |
| 6-month PFS rate | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 6 months | 6-month progression-free survival rate |
| OS | from the date of first dose until the date of death from any cause，assessed up to 2 years | Overall survival |
| 6-month OS rate | from the date of first dose until the date of 6-month | 6-month overall survival rate |
Countries
China
Outcome results
None listed