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Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric 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: NCT04208347
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Ruijin Hospital

Brief Summary:
The study is being conducted to evaluate the efficacy, safety and tolerability of chemotherapy and apatinib with or without camrelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

Condition or disease Intervention/treatment Phase
Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma Drug: Apatinib 250mg Drug: Camrelizumab Drug: S-1, Oxaliplatin Drug: Apatinib 500mg Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Resectable Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: A Multicenter, Randomized Phase II-III Trial
Actual Study Start Date : December 18, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : October 2022

Arm Intervention/treatment
Experimental: Apatinib and Camrelizumab and S-1 and Oxaliplatin Drug: Apatinib 250mg
Apatinib 250mg

Drug: Camrelizumab
Camrelizumab 200mg

Drug: S-1, Oxaliplatin
S-1, Oxaliplatin, q3w

Experimental: Apatinib and S-1 and Oxaliplatin Drug: S-1, Oxaliplatin
S-1, Oxaliplatin, q3w

Drug: Apatinib 500mg
Apatinib 500mg

Active Comparator: S-1 and Oxaliplatin Drug: S-1, Oxaliplatin
S-1, Oxaliplatin, q3w




Primary Outcome Measures :
  1. Major pathological response(MPR) [ Time Frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment ]

Secondary Outcome Measures :
  1. Pathological Complete Response (pCR) [ Time Frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment ]
  2. PFS [ Time Frame: up to 2 years ]
  3. Margin-free (R0) resection rate [ Time Frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment ]
  4. DFS [ Time Frame: up to 2 years ]
  5. OS [ Time Frame: up to 3 years ]
  6. Downstaging of N stage [ Time Frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment ]
  7. AEs [ Time Frame: Up to approximately 18 months ]


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:

  • Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0;
  • Plans to proceed to surgery following pre-operative chemotherapy.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
  • Has adequate organ function.
  • Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
  • Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
  • Has life expectancy of greater than 12 months.

Exclusion Criteria:

  • Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
  • Known hypersensitivity to any of the study drugs or excipients.
  • Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
  • Congenital or acquired immune deficiency (e.g. HIV infected)

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): NCT04208347


Contacts
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Contact: Yanan Zheng +8613636404065 ianzyn@163.com
Contact: Chen LI +8613916632699 leedoctor@sina.com

Locations
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China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, China
Contact: Yanan Zheng    +8613636404065      
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: Zhenggang Zhu Ruijin Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ruijin Hospital
ClinicalTrials.gov Identifier: NCT04208347    
Other Study ID Numbers: DRAGON - IV
Ahead-G208 ( Other Identifier: Ruijin Hospital )
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 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
Oxaliplatin
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action