Trials / Unknown
UnknownNCT04486651
HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HX008 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 560 (estimated)
- Sponsor
- Taizhou Hanzhong biomedical co. LTD · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-blinded, multicenter study to evaluate the efficacy and safety of HX008 injection combined with irinotecan versus placebo combined with irinotecan as second-line therapy in patients with adcanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have had tumor progression after first-line treatment with platinum and/or fluropyrimidine therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Irinotecan Hydrochloride Injection | 160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle. |
| DRUG | HX008 | 200 mg administered as IV infusion on Day 1 of each 21-day cycle. |
| DRUG | Placebo | Administered as IV infusion on Day 1 of each 21-day cycle. |
Timeline
- Start date
- 2020-09-16
- Primary completion
- 2023-08-10
- Completion
- 2023-08-10
- First posted
- 2020-07-24
- Last updated
- 2021-01-28
Locations
64 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04486651. Inclusion in this directory is not an endorsement.