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A Study of CS1001 in Subjects With Gastric Adenocarcinoma or Gastro-Esophageal Junction Adenocarcinoma

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: NCT03802591
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

Brief Summary:
This is a phase III, multi-Center, randomized, placebo-controlled trial to investigate the efficacy and safety of CS1001 in combination with Oxaliplatin and Capecitabine (XELOX) chemotherapy in first-line subjects with unresectable locally advanced or metastatic gastric adenocarcinoma (GC) or gastro-esophageal junction (GEJ) adenocarcinoma.

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Drug: CS1001 monoclonal antibody Drug: CS1001 placebo Drug: Oxaliplatin Drug: Capecitabine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Randomized, Phase III Study of CS1001 in Combination With XELOX Chemotherapy Compared to Placebo in Combination With XELOX Chemotherapy in Subjects With Unresectable Locally Advanced or Metastatic GC or GEJ Adenocarcinoma
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: CS1001 monoclonal antibody
in combination with Oxaliplatin and Capecitabine
Drug: CS1001 monoclonal antibody
Participant will receive CS1001 monoclonal antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months

Drug: Oxaliplatin
Administered as an IV infusion on Day 1 Q3W

Drug: Capecitabine
Administered by oral, twice a day on Day 1 - Day 14 of each cycle.

Placebo Comparator: CS1001 placebo
in combination with Oxaliplatin and Capecitabine
Drug: CS1001 placebo
Participant will receive CS1001 placebo antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months

Drug: Oxaliplatin
Administered as an IV infusion on Day 1 Q3W

Drug: Capecitabine
Administered by oral, twice a day on Day 1 - Day 14 of each cycle.




Primary Outcome Measures :
  1. Progression-free survival (PFS) evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to 27 months ]
  2. Overall survival (OS) [ Time Frame: from the date of randomization to the first date of recorded all-cause death, assessed up to 38 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Age ≥ 18 years but ≤ 75 years
  2. Being able to follow the protocol requirements as per investigator's evaluation.
  3. Provide written informed consent before any protocol-related procedure (that is not a part of subject's routine care) is carried out.
  4. Unresectable locally advanced or metastatic gastric carcinoma (GC) or gastro-esophageal junction (GEJ) carcinoma, and have histologically confirmed predominant adenocarcinoma.
  5. The subject may have at least a measurable lesion or an evaluable lesion, if not measurable; the investigator will carry out evaluation according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to randomization.
  6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
  7. Expected survival ≥ 3 months.
  8. Subject must not have received systemic treatment (including HER2 inhibitor) for advanced or metastatic gastric carcinoma.
  9. Subject must provide tumor tissue samples for biomarker analysis in order to determine the expression of PD-L1.
  10. Permitted prior treatment: Subjects with GC or GEJ carcinoma priorly treated with adjuvant or neoadjuvant therapy, who experience clinical progression of disease at least 6 months during treatment or after treatment are allowed to be enrolled.
  11. Subjects must have adequate organ function as assessed in the laboratory tests
  12. Subjects with active hepatitis B or active hepatitis C must receive antiviral treatment for at least 14 days prior to the first dose of study treatment and pass the hepatitis B virus (HBV) DNA titer test (≤ 500 IU/mL or 2500 copies/mL) and hepatitis C virus (HCV) RNA test (≤ lower limit of detection) before being enrolled. The subject should be willing to continue effective anti-viral treatment during the study.
  13. Female subject with childbearing potential must have negative serum pregnancy test result at screening, except for those with available sterilization operation record or post-menopausal subjects. Female subject with childbearing potential or male subjects and their partners must agree to take effective contraceptive measures from the day of signing ICF till at least 6 months after the last dosing of investigational product.

Exclusion Criteria:

  1. Known HER-2 positivity.
  2. A known additional primary malignancy that occurred within 5 years prior to the first dose of investigational treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
  3. Known primary central nerve system (CNS) tumor or meningeal metastasis, or unstable CNS metastasis (symptomatic within 4 weeks before first dose of investigational product, requiring corticosteroid treatment, or without radiologic evidence supporting stable status for over 4 weeks prior to the first dose of investigational product).
  4. Any severe or uncontrolled systemic disease, for example diabetes mellitus or hypertension, that may increase the risk associated with participation or investigational product administration, or compromise subject's ability to receive investigational product, as per investigator's judgment.
  5. Known positive human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
  6. Has had prior chemotherapy, immune therapy, biological therapy (including cancer vaccine, cytokine therapy or growth factors to control cancer) used as systemic treatment for cancer, within 14 days before the first dose of investigational product.
  7. Any prior treatment of antibody/drug that targets at T-cell coregulatory proteins or immune checkpoints pathways(including anti-PD-1, anti-PD-L1, anti-CTLA4, anti-TIM3, anti-LAG3 antibody, etc.).
  8. Subjects with conditions that in the investigator's opinion are not suitable for participating in this trial.

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): NCT03802591


Contacts
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Contact: Wendie Yuan +86 21 61097678 ext 8118 cstonera@cstonepharma.com

Locations
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China
Beijing Cancer Hospital Recruiting
Beijing, China
Contact: Lin Shen         
Sponsors and Collaborators
CStone Pharmaceuticals
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Responsible Party: CStone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03802591    
Other Study ID Numbers: CS1001-303
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020

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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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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Capecitabine
Oxaliplatin
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents