2024-10-15
minor
Study Status, Eligibility v6
Eligibility criteria-8,208 characters
Key Inclusion Criteria:
Patients are eligible for the study if they meet all of the following criteria:
Male or female aged 18-75 years (inclusive) when signing the ICF
Histopathologically confirmed unresectable metastatic/recurr [...] eatment to recurrence or progression must exceed 12 months.
The interval between the end of previous traditional Chinese medicine treatment and the first dose in this study should be ≥ 2 weeks
Recovering of previous treatment-related AEs to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade ≤ 1 (except for alopecia)
With at least [...] [...]
2024-06-06
minor
Study Status, Study Description v5
Study description-49 characters
[...] n the test group and 50 in the control group).Approximately 654568 patients will be enrolled in the Part III (Phase III study, 327284 in the test group and 327284 in the control group).
Part II (Phase II study): Approximat [...] hase III study): A total of approximately 75 study sites in 73 countries(including China, the United States, BrazilJapan, Indonesia, Russia, Poland, Spain, etc.) will participate.
The study consists of a screening period [...]
2024-05-31
notable
Active, Not Recruiting→Recruiting Study Identification, Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v4
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2024-11-24→2025-09-24
Completion date2025-06-30→2026-12-30
Enrollment target114→568
Study sites4→5
Eligibility criteria+215 characters
[...] owing criteria:
Male or female aged 18-75 years (inclusive) at the time ofwhen signing the informed consent form (ICF)
Histopathologically confirmedunresectableconfirmed unresectable metastatic/recurrent colorectal adenocarcinoma
ExpectedLife survivalexpectancy ≥ 12 weeks
Have not received any previous systemic antineoplasticanti-tumor drug therapytreatment for metastatic/recurrent colorectal adenocarcinoma
TimeFor from last treatment to recurrence or progression ≥ 12 monthsforpatientsparticipants who have previously received neoadjuvant/adjuvant therapy, the time from the last treatment to re [...] [...]
Secondary endpoints5 to 6 entries
PFS2
2022-12-19
minor
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions v3
Enrollment target115→114
InterventionsHLX04/Avastin (Drug), HLX10/Placebo (Drug)→HLX04、 (Drug), HLX10 (Drug)
Study title+26 characters
A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)
2022-04-27
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Arms and Interventions, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
PhasePhase 3→Phase 2/3
Enrollment targetestimated 666→confirmed 115
Study sitesdetails revised at 4 of 4 sites
2021-11-08
notable
Not Yet Recruiting→Recruiting Study Status, Study Description, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-09-18→confirmed 2021-03-10
Study description+1,019 characters
Patients with confirmed unresectable metastatic/recurrent colorectal adenocarcinoma who have not received systemic anti-neoplastic therapy for metastatic/recurrent lesions will be included in this study.Approximately 6-12 patients will be enrolled in the Part I (Safety Run-in Period).Approximately 1 [...]
2020-09-07
minor
Original filing