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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

PD-1 Inhibitor Combined With FOLFOX Neoadjuvant Therapy for Resectable Gastric and Gastroesophageal Junctional Adenocarcinoma

Clinicaltrials.gov identifier NCT03939962

Recruitment Status Not yet recruiting

First Posted May 7, 2019

Last update posted May 8, 2019

Study Description

Brief summary:

The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of immume checkpoint inhibitor PD-1 SHR1210 combined with chemotherapy in neoadjuvant therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma. In addition ,the investigators will explore the relationship between the immunophenotype of gastric cancer and the efficacy and drug resistance of immunotherapy combined with chemotherapy, and screen out biomarkers that can predict the efficacy of immunotherapy.

  • Condition or Disease:Gastric Cancer
  • Intervention/Treatment: Drug: SHR1210 combined with FOLFOX
  • Phase: Phase 2
Detailed Description

Neoadjuvant chemotherapy and neoadjuvant radiotherapy and chemotherapy can not only improve the surgical resection rate and postoperative pathological remission rate, but also prolong the postoperative recurrence-free survival and benefit patients.Recent studies have confirmed that immume point inhibitors PD-1 and CTLA-4 monoclonal antibody have a certain effect in advanced gastric and gastroesophageal junction adenocarcinoma which had experienced multi-line treatment. Furthermore,the FOLFOX protocol is recommended as a new adjuvant treatment for locally advanced gastric cancer.In order to further improve the surgical resection rate and survival rate by improving the efficacy of neoadjuvant therapy for locally advanced gastric and gastroesophageal junction adenocarcinoma, the investigators selected PD-1 monoclonal antibody combined with FOLFOX neoadjuvant therapy for locally advanced gastric and gastroesophageal junctions Adenocarcinoma.The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of immume checkpoint inhibitor PD-1 SHR1210 combined with chemotherapy in neoadjuvant therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma. In addition ,the investigators will explore the relationship between the immunophenotype of gastric cancer and the efficacy and drug resistance of immunotherapy combined with chemotherapy, and screen out biomarkers that can predict the efficacy of immunotherapy.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 60 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Phase Ⅱ Study of PD-1 Inhibitor Combined With FOLFOX Neoadjuvant Therapy for Resectable Gastric and Gastroesophageal Junctional Adenocarcinoma
  • Estimated Study Start Date: June 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: June 2021
Arms and interventions
Arm Intervention/treatment
Experimental: treatment group
SHR1210 combined with FOLFOX repeat every 14 days for a total of 4 cycles.
Drug: SHR1210 combined with FOLFOX
SHR1210, iv, 200 mg d1, 30-minute intravenous infusion, repeated every 14 days. mFOLFOX6:Oxaliplatin 85mg/m2 ivgtt 2h d1,5-fluorouracil 400mg/m2 iv d1,leucovorin 400mg/m2 ivgtt 2h d1,5-fluorouracil 2.4mg/m2 CIV 46h, repeated every 14 days Patients who have no disease progression and can tolerate surgery receive surgery. When the investigator believes that the patient is not suitable for continued medication or according to the RECIST 1.1 standard, the evaluation is PD and the medication is over. The PD-1 monoclonal antibody does not allow for reductions and can only delay or suspend medication.
Outcome Measures
  • Primary Outcome Measures: 1. R0 resection rate [ Time Frame: up to 2 years ]
    Tumor tissue was completely resected as a percentage of all surgical patients
  • 2. pathological complete response (pCR) rate [ Time Frame: up to 2 years ]
    the rate of no residual invasive cancer, or only carcinoma in situ in both the excised breast and axillary lymph node
  • Secondary Outcome Measures: 1. Progression-free Survival (PFS) [ Time Frame: up to 2 years ]
    From date of randomization until the date of first documented progression or date of death from any cause
  • 2. Overall survival(OS) [ Time Frame: up to 2 years ]
    the first day of treatment to death or last survival confirm date
Eligibility Criteria
  • Ages Eligible for Study: 18 to 73 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. 18-73 years old; male or female

2. confirmed gastric and gastroesophageal junction adenocarcinoma by Gastroscopic biopsy
histopathological examination

3. Imaging (CT/MRI) and ultrasound gastroscopy confirmed: cT ≥ T2 and / or regional lymph
node positive (N +);

4. ECOG score: 0~2 points;

5. Expected survival period ≥ 12 weeks;

6. A histological specimen can be provided for secondary testing;

7. The main organ function meets the following criteria within 7 days before treatment:

Blood routine examination criteria (without blood transfusion within 14 days):

Hemoglobin (HB) ≥ 90g / L; The absolute value of neutrophils (ANC) ≥ 1.5 × 109 / L;
Platelet (PLT) ≥ 80 × 109 / L (2) Biochemical examinations must meet the following
criteria: Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine
aminotransferase (ALT) Aspartate aminotransferase (AST) ≤ 2.5 * ULN; serum creatinine
(Cr) ≤ 1.5 * ULN or creatinine clearance (CCr) ≥ 60ml / min; (3) Doppler ultrasound
assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).

8. Women of childbearing age should agree to use contraceptives (such as intrauterine
devices, contraceptives or condoms) during the study period and within 6 months after
the end of the study; negative serum or urine pregnancy test within 7 days prior to
study enrollment and must be non-lactating patients; men should agree to patients who
must use contraception during the study period and within 6 months after the end of
the study period.

9. The patient volunteered to participate in the study and signed an informed consent
form;

Exclusion Criteria:

1. Exceeding or currently suffering from other malignant tumors within 5 years, except
for cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors
[Ta (non-invasive tumor), Tis (in situ carcinoma) And T1 (tumor infiltrating basement
membrane)];

2. Patients with a high risk of bleeding or fistula due to the apparent invasion of
adjacent organs (aorta or trachea);

3. Before starting treatment, subject administrated corticosteroids (day> 10 mg
equivalent dose prednisone), or other immunosuppressive drugs for systemic treatment
of a disease within 14 days . In the absence of active autoimmune disease, >10 mg of
daily prednisone equivalent dose of inhaled or topical steroid and adrenal replacement
steroid doses are permitted;

4. Anyone who has received any anti-tumor treatment in the past;

5. Significantly malnourished patients. Exclusion is performed if the patient is
receiving intravenous fluids or is required to be hospitalized for continuous infusion
therapy. Patients with good nutrition control ≥ 28 days can be enrolled before
randomization;

6. Participants who received live/attenuated vaccine within 30 days of the first
treatment;

7. Unresolved toxicity due to any previous treatment above CTC AE4.0 Level 2, excluding
neurotoxicity of ≤2 caused by hair loss and oxaliplatin;

8. Allergic reactions and adverse drug reactions:

1. a history of allergies to the ingredients of the study drug;

2. contraindications to any study drug (fluorouracil or oxaliplatin) in the
chemotherapy regimen.

9. Patients with any severe and/or uncontrolled disease, including:

1. patients with hypertension who are not well controlled by antihypertensive drug
(systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg);

2. with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia
(including QTc ≥ 480ms) and ≥ grade 2 congestive heart failure (New York Heart
Association (NYHA) classification);

3. Severe or uncontrolled disease or active infection (≥CTCAE grade 2 infection),
which the investigator believes may increase the risk associated with study
participation, study drug administration, or affect the subject's ability to
receive study medication;

4. Renal failure requires hemodialysis or peritoneal dialysis;

5. a history of immunodeficiency, including HIV-positive or other acquired,
congenital immunodeficiency disease, or a history of organ transplantation;

6. Patients with diabetes who have poor glycemic control (fasting blood glucose
(FBG) > 10 mmol/L); subjects with active, known or suspected autoimmune diseases.
Subjects with type 1 diabetes, residual hypothyroidism caused by autoimmune
thyroiditis requiring hormone replacement therapy, and skin diseases that do not
require systemic treatment (such as vitiligo, psoriasis or alopecia) can be
enrolled;

7. patients with seizures and requiring treatment;

8. The subject has an interstitial lung disease that is symptomatic or may interfere
with the discovery or management of suspected drug-related lung toxicity;
previous and current subjects with a history of pulmonary fibrosis, interstitial
pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia,
severe impaired lung function, etc. that may interfere with the detection and
management of suspected drug-related lung toxicity;

10. Patients with gastrointestinal diseases such as intestinal obstruction (including
incomplete intestinal obstruction) or those who may have caused gastrointestinal
bleeding, perforation or obstruction;

11. Patients who underwent surgical treatment, incisional biopsy or significant traumatic
injury within 28 days prior to enrollment;

12. In the 4 weeks prior to enrollment, patients with any bleeding event ≥ CTCAE 3 have
unhealed wounds, ulcers or fractures;

13. Overactive/venous thrombosis events within 3 months, such as cerebrovascular accidents
(including transient ischemic attacks), deep static Pulmonary thrombosis and pulmonary
embolism;

14. Prepare or accept previous allogeneic or allogeneic bone marrow transplantation,
including liver transplantation;

15. According to the investigator's judgment, there is a concomitant disease that
seriously harms the patient's safety or affects the patient's completion of the study;

16. Cannot perform biopsy to provide histological specimens;

17. those who have a history of psychotropic substance abuse and are unable to quit or
have a mental disorder; Prepare or accept previous allogeneic or allogeneic bone
marrow transplants, including liver transplants;

18. Urine routine showed urinary protein ≥ 2+ and confirmed 24-hour urine protein
quantitation > 1.0 g;

19. Patients with brain metastases;

20. Patients who have participated in other clinical trials of anti-tumor drugs within
four weeks.

Contacts and Locations
Contacts

Contact: Ying Liu 13783604602 yaya7207@126.com

Locations
Sponsors and Collaborators

Henan Cancer Hospital

Investigators

Principal Investigator: Ying Liu HeNanHenan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

More Information
  • Responsible Party: Henan Cancer Hospital
  • ClinicalTrials.gov Identifier: NCT03939962 History of Changes
  • Other Study ID Numbers: HNGC-004
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 8, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Adenocarcinoma