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HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04486651
Recruitment Status : Not yet recruiting
First Posted : July 24, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Taizhou Hanzhong biomedical co. LTD

Brief 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.

Condition or disease Intervention/treatment Phase
Stomach Cancer Drug: Irinotecan Hydrochloride Injection Drug: HX008 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : August 10, 2020
Estimated Primary Completion Date : August 10, 2023
Estimated Study Completion Date : August 10, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: HX008 plus Irinotecan
Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
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.

Placebo Comparator: Placebo plus Irinotecan
Participants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
Drug: Irinotecan Hydrochloride Injection
160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.

Drug: Placebo
Administered as IV infusion on Day 1 of each 21-day cycle.




Primary Outcome Measures :
  1. Overall Survival (OS) in All Participants [ Time Frame: Up to approximately 36 months ]
    OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm.

  2. Overall Survival (OS) in Participants With PD-L1 CPS≥1 [ Time Frame: Up to approximately 36 months ]
    OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm with PD-L1 CPS≥1.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 36 months ]
    PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.

  2. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 36 months ]
    ORR was defined as the percentage of participants who have a complete response (CR) or a partial response (PR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.

  3. Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 36 months ]
    DCR was defined as the percentage of participants who have a CR or a PR or a stable disease (SD), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.

  4. Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 36 months ]
    DOR was defined as the time from the first documented evidence of a response of CR or PR, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Understood and signed an informed consent form.
  • Age ≥ 18 and ≤ 75 years old, male or female.
  • Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ).
  • Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing platinum and/or fluoropyrimidine therapy.
  • Willing to provide tissue for PD-L1 biomarker analysis.
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.
  • Life expectancy ≥ 3 months.
  • Has adequate organ function.
  • Female participants of childbearing potential should have a negative pregnancy within 72 hours before the randomization. Male and female participants should agree to use an adequate method of contraception during the experiment and 1 year after the last administration of the test drugs.

Exclusion Criteria:

  • Has squamous cell or undifferentiated gastric cancer.
  • Diagnosed additional maliganancy within 3 years prior to randomization with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
  • Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to agents administered more than 4 weeks earlier.
  • Has had prior chemotherapy,radiation therapy or targeted small molecular therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to a previously administrated agent.
  • Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has uncontrolled ascites, pleural effusion, or pericardial effusion.
  • Has active autoimmune disease that has required systemic treatment in past 2 years.
  • Has received a major surgery within 4 weeks prior to randomization.
  • Has received system treatment with corticosteroids (dose >10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
  • Has incomplete intestinal obstruction, active gastrointestinal hemorrhage and perforation.
  • Has a history of non-infectious pneumonitis that required steriods or has current pneumonitis.
  • Has any serious and/or uncontrolled disease.
  • Has active viral infection.
  • Has received a live vaccine within 30 days prior to the first dose of trial treatment.
  • Has participated in other anticancer drug clinical trials within 4 weeks.
  • According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04486651


Contacts
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Contact: Jing Huang, MD 010-87788113 huangjingwg@163.com

Locations
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China, Beijing
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Sponsors and Collaborators
Taizhou Hanzhong biomedical co. LTD
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Responsible Party: Taizhou Hanzhong biomedical co. LTD
ClinicalTrials.gov Identifier: NCT04486651    
Other Study ID Numbers: HX008-III-GC-01
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents