Clinical trial NCT04150575: A Clinical Study to Evaluate Efficacy and Safety of HLX10 Combined With Albumin-Bound Paclitaxel in Patients With Advanced Cervical Cancer Who Have Progressive Disease or Intolerable Toxicity After First-Line Standard Chemotherapy
Official title: A Single-Arm, Open-Label, Multicentre, Phase II Clinical Study to Evaluate Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Combined With Albumin-Bound Paclitaxel in Patients With Advanced Cervical Cancer Who Have Progressive Disease or Intolerable Toxicity After First-Line Standard Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Cancer
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2019-11-05
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: ORR
timeFrame: up to 2 years
Secondary outcomes:
measure: ORR
timeFrame: up to 2 years
measure: PFS
timeFrame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
measure: 6-month PFS rate
timeFrame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 6 months
measure: OS
timeFrame: from the date of first dose until the date of death from any cause，assessed up to 2 years
measure: 6-month OS rate
timeFrame: from the date of first dose until the date of 6-month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: lingying wu
role: PRINCIPAL_INVESTIGATOR
References: