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Nivolumab Combined With SOX Used in the Perioperative Treatment

Primary Purpose

Immune Suppression, Gastric Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
nivolumab combined with SOX
Sponsored by
Xiangdong Cheng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Suppression

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must meet all of the following inclusion criteria to be enrolled in the study: 1. Patients voluntarily participate in the study and sign the informed consent form; 2. Age ≥ 18 years and ≤ 75 years; 3. Have pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 4. Patients with gastric or gastroesophageal junction adenocarcinoma at the clinical staging of cT3-4 or N+, M0 (staging according to AJCC version 8) who could be radically resected as determined by CT and laparoscopy; 5. Have not received anti-tumor therapy (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. Planned surgical treatment after completion of neoadjuvant therapy; 7. Able to swallow tablets normally; 8. ECOG score 0-1; 9. Expected survival >=12 months; 10. Main organ functions normal, i.e., meeting the criteria below: Blood routine examination criteria shall meet: (No blood transfusion or blood products within 14 days, no G-CSF or other hematopoietic stimulating factors are used for correction) Absolute neutrophil count ≥1.5×109/L; Platelet ≥80×109/L; Hemoglobin ≥ 80 g/L Criteria for biochemical tests: Total bilirubin <1.5×ULN; ALT and AST≤2.5×ULN; Serum Cr ≤ 1.5 × ULN or endogenous creatinine clearance > 50 ml/min (males: Endogenous creatinine clearance rate = ((140-age) × body weight)/(72 × serum Cr); female: endogenous creatinine clearance rate = ((140-age) × body weight)/(72 × serum Cr) × 0.85; body weight unit: kg; serum Cr unit: mg/mL): 11. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and be willing to use a highly effective method of contraception during the trial and for 120 days after the last dose. Male subjects with partners of childbearing potential should be surgically sterilized or agree to use highly effective methods of contraception during the trial and for 120 days after the last dose; Exclusion Criteria: Patients with any of the following are not to be enrolled in the study: Patients with unresectable factors, including unresectable tumor causes or unresectable surgical contraindications or refusal of surgery; Previous or concurrent other malignancy; Suffering from any chronic or major illness considered intolerable to treatment (eg, severe cardiac disease, uncontrolled hypertension, some degree of hepatic or renal dysfunction, etc.) Patients who have previous gastrointestinal perforation, abdominal abscess or recent (within 3 months) intestinal obstruction or imaging and clinical symptoms suggestive of intestinal obstruction; Patients having clinically significant bleeding symptoms or definite bleeding tendency within 3 months before the first dose of study drug, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or suffering from vasculitis; if stool occult blood is positive at baseline, reexamination may be performed; if stool occult blood remains positive after reexamination, gastroscopy is required (except for patients having gastroscopy within 3 months before enrollment to exclude such condition); Patients in the active stage of infection requiring treatment (such as antibacterial drugs, antiviral drugs, antifungal drugs); Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/ml; hepatitis C reference: HCV antibody positive and HCV viral copy number > upper limit of normal); Patients with congenital or acquired immunodeficiency (such as HIV infection); Patients with any active autoimmune disease or history of autoimmune disease with potential relapse; Planned or previous organ or allogeneic bone marrow transplant; Patients with current interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or interstitial lung disease requiring steroids, or subjects with active pneumonia or severe lung function impairment on screening CT; active pulmonary tuberculosis; Ongoing or recent treatment with immunosuppressive drugs or systemic corticosteroids to achieve immunosuppression; Patients who have received a live attenuated vaccine within 28 days prior to the first dose of study drug or who require administration of such vaccine during treatment or within 60 days after the last dose; Patients with known hypersensitivity to any of the study drugs or any of their excipients; Nursing mothers; Any factors that, in the judgment of the investigator, could affect patient safety and force the termination of the study

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nivolumab combined with SOX

Arm Description

Medication regimen: nivolumab + SOX (3 cycles) before surgery → radical surgery (D2) → nivolumab + SOX (3 cycles) after surgery → nivolumab monotherapy maintenance (11 cycles); Surgery is performed 2 - 6 weeks after the last dose of neoadjuvant therapy, and postoperative adjuvant therapy is initiated at least 4 weeks after surgery.

Outcomes

Primary Outcome Measures

pathological complete response rate (pCR)
pCR

Secondary Outcome Measures

3-year DFS
3-year DFS

Full Information

First Posted
November 2, 2022
Last Updated
February 11, 2023
Sponsor
Xiangdong Cheng
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1. Study Identification

Unique Protocol Identification Number
NCT05739045
Brief Title
Nivolumab Combined With SOX Used in the Perioperative Treatment
Official Title
A Multicenter, Prospective, Phase Ⅱ Clinical Study of Nivolumab Combined With SOX in the Perioperative Treatment of Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiangdong Cheng

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To evaluate the pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma;
Detailed Description
Primary Objective To evaluate the pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma; Secondary Objectives To evaluate the major pathological response rate (mPR), R0 resection rate, lymph node status after neoadjuvant therapy (ypN stage), 3-yr-DFS, OS, and safety and tolerability of nivolumab combined with SOX in the periopera

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Suppression, Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nivolumab combined with SOX
Arm Type
Experimental
Arm Description
Medication regimen: nivolumab + SOX (3 cycles) before surgery → radical surgery (D2) → nivolumab + SOX (3 cycles) after surgery → nivolumab monotherapy maintenance (11 cycles); Surgery is performed 2 - 6 weeks after the last dose of neoadjuvant therapy, and postoperative adjuvant therapy is initiated at least 4 weeks after surgery.
Intervention Type
Drug
Intervention Name(s)
nivolumab combined with SOX
Intervention Description
nivolumab + SOX (3 cycles) before surgery → radical surgery (D2) → nivolumab + SOX (3 cycles) after surgery → nivolumab monotherapy maintenance (11 cycles);
Primary Outcome Measure Information:
Title
pathological complete response rate (pCR)
Description
pCR
Time Frame
3 months
Secondary Outcome Measure Information:
Title
3-year DFS
Description
3-year DFS
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be enrolled in the study: 1. Patients voluntarily participate in the study and sign the informed consent form; 2. Age ≥ 18 years and ≤ 75 years; 3. Have pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 4. Patients with gastric or gastroesophageal junction adenocarcinoma at the clinical staging of cT3-4 or N+, M0 (staging according to AJCC version 8) who could be radically resected as determined by CT and laparoscopy; 5. Have not received anti-tumor therapy (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. Planned surgical treatment after completion of neoadjuvant therapy; 7. Able to swallow tablets normally; 8. ECOG score 0-1; 9. Expected survival >=12 months; 10. Main organ functions normal, i.e., meeting the criteria below: Blood routine examination criteria shall meet: (No blood transfusion or blood products within 14 days, no G-CSF or other hematopoietic stimulating factors are used for correction) Absolute neutrophil count ≥1.5×109/L; Platelet ≥80×109/L; Hemoglobin ≥ 80 g/L Criteria for biochemical tests: Total bilirubin <1.5×ULN; ALT and AST≤2.5×ULN; Serum Cr ≤ 1.5 × ULN or endogenous creatinine clearance > 50 ml/min (males: Endogenous creatinine clearance rate = ((140-age) × body weight)/(72 × serum Cr); female: endogenous creatinine clearance rate = ((140-age) × body weight)/(72 × serum Cr) × 0.85; body weight unit: kg; serum Cr unit: mg/mL): 11. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and be willing to use a highly effective method of contraception during the trial and for 120 days after the last dose. Male subjects with partners of childbearing potential should be surgically sterilized or agree to use highly effective methods of contraception during the trial and for 120 days after the last dose; Exclusion Criteria: Patients with any of the following are not to be enrolled in the study: Patients with unresectable factors, including unresectable tumor causes or unresectable surgical contraindications or refusal of surgery; Previous or concurrent other malignancy; Suffering from any chronic or major illness considered intolerable to treatment (eg, severe cardiac disease, uncontrolled hypertension, some degree of hepatic or renal dysfunction, etc.) Patients who have previous gastrointestinal perforation, abdominal abscess or recent (within 3 months) intestinal obstruction or imaging and clinical symptoms suggestive of intestinal obstruction; Patients having clinically significant bleeding symptoms or definite bleeding tendency within 3 months before the first dose of study drug, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or suffering from vasculitis; if stool occult blood is positive at baseline, reexamination may be performed; if stool occult blood remains positive after reexamination, gastroscopy is required (except for patients having gastroscopy within 3 months before enrollment to exclude such condition); Patients in the active stage of infection requiring treatment (such as antibacterial drugs, antiviral drugs, antifungal drugs); Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/ml; hepatitis C reference: HCV antibody positive and HCV viral copy number > upper limit of normal); Patients with congenital or acquired immunodeficiency (such as HIV infection); Patients with any active autoimmune disease or history of autoimmune disease with potential relapse; Planned or previous organ or allogeneic bone marrow transplant; Patients with current interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or interstitial lung disease requiring steroids, or subjects with active pneumonia or severe lung function impairment on screening CT; active pulmonary tuberculosis; Ongoing or recent treatment with immunosuppressive drugs or systemic corticosteroids to achieve immunosuppression; Patients who have received a live attenuated vaccine within 28 days prior to the first dose of study drug or who require administration of such vaccine during treatment or within 60 days after the last dose; Patients with known hypersensitivity to any of the study drugs or any of their excipients; Nursing mothers; Any factors that, in the judgment of the investigator, could affect patient safety and force the termination of the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng Xiangdong
Phone
0086-571-881280
Email
Chengxd516@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng Xiangdong
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Xiangdong, MD
Phone
+0086-571-88128041
Email
Chengxd516@126.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Medication regimen: nivolumab + SOX (3 cycles) before surgery → radical surgery (D2) → nivolumab + SOX (3 cycles) after surgery → nivolumab monotherapy maintenance (11 cycles); Surgery is performed 2 - 6 weeks after the last dose of neoadjuvant therapy, and postoperative adjuvant therapy is initiated at least 4 weeks after surgery.

Learn more about this trial

Nivolumab Combined With SOX Used in the Perioperative Treatment

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