Camrelizumab Combined With SOX and/or Apatinib for Locally Advanced Gastric Cancer

NCT04792515 | Unknown Phase 2 DMC

• 1 other identifier: XJTU1AFCT-2021-003
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to evaluate the efficacy and safety of camrelizumab in combination with SOX and/or apatinib in the treatment of locally advanced gastric cancer or gastroesophageal junction adenocarcinoma.The primary endpoint was pathologic complete response (PCR).In addition, secondary efficacy endpoints include R0 resection rate, objective response rate (ORR), and 1-year progression-free survival rate (PFSR) . They were set to demonstrate the therapeutic benefit of camrelizumab combined with SOX in patients 。

Conditions

Locally Advanced Gastric Cancer

Keywords

Camrelizumab ,Efficacy ,Safety

Outcome Measures

Primary Outcomes (1)

• pathologic complete response (PCR)

  The enhancement lesions disappeared completely

  6month

Secondary Outcomes (3)

• R0 resection rate

  6month

• ORR

  12month

• Percentage of Progression-free survival (1-PFSR)

  12month

Study Arms (1)

treatment group

EXPERIMENTAL

Patients were treated with camrelizumab combined with SOX/ or apatinib

Drug: Camrelizumab combined with SOX/ or apatinib

Interventions

Camrelizumab combined with SOX/ or apatinib DRUG

Camrelizumab: every 3 weeks (21 days) was given as one administration cycle. 200mg was given intravenously on the first day of each cycle. Dose adjustment is not allowed. Delayed administration is allowed. Apatinib mesylate: 250mg, qd, stopped 28 days before surgery, and can be used by the investigator according to the patient's recovery 28 days after surgery. Chemotherapy: The SOX regimen consisted of one cycle every 3 weeks (21 days).Dose adjustment is allowed. Delayed administration is allowed. Oxaliplatin (OXA) : 130mg/m2, intravenous infusion, d1, infusion more than 2 hours. Tigio Capsules (S-1) : Take orally after breakfast and dinner, twice daily, d1-14. The dosing time window is ±3 days, but within 72 hours before each dosing, subjects must complete an examination that includes all clinical requirements to assess tolerance for continued dosing.

treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign written informed consent before screening;
• Male or female, ≥18 years old;
• Have at least one measurable lesion according to RECIST1.1;
• ECOG physical status score 0\~1;
• Pathologically confirmed local progression (CT3/CT4N+M0) of gastric cancer or adenocarcinoma of the gastroesophageal junction without any previous treatment (Siewert II or III).
• According to the clinical staging standard, surgical treatment is planned after neoadjuvant chemotherapy.
• Expected survival of more than 3 months;
• The main organs function normally, following criteria:
• I. Blood routine (no blood transfusion, no use of granulocyte colony stimulating factor (G-CSF) or other hematopoietic stimulating factor correction within 14 days before screening examination) : neutrophils ≥1.5× 109 /L, platelets ≥100×109/L, hemoglobin ≥90g/L;White blood cells acuity 3.5 x l09 / L II. Liver function: ALT and AST, ALT and AST ≤ 2.5×ULN; Total bilirubin (TBil) ≤ 1.5×ULN (Gilbert syndrome patients, ≤ 3×ULN); III. Renal function: serum creatinine (CR) ≤ 1.5×ULN or creatinine clearance (CCR) ≥60mL/ min; IV. Coagulation function: APTT, INR, PT ≤ 1.5×ULN;

You may not qualify if:

• Gastric squamous cell carcinoma, adenosquamous cell carcinoma, small cell carcinoma and undifferentiated gastric carcinoma confirmed by pathology;
• Positive HER-2 test (IHC3+ or IHC2+ amplified by FISH);
• Any previous anti-tumor therapy (including chemotherapy, radiotherapy, hormone therapy, and molecular targeted therapy);
• Cardiac and pyloric obstruction affects the patient's eating and gastric emptyor and has difficulties to swallow tablets;
• Previous immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, anti CD137 or anti CTLA-4 antibodies or any other antibodies or drugs that target co-stimulation of T cells or immune checkpoint pathways;
• Has developed or is currently having other malignant tumors within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, or other tumors/cancers that have undergone radical treatment and have been free of disease for at least 5 years;
• Perimeter neuropathy is grade 2 or greater according to the common adverse event terminology (NCI-CTCAE V5.0);
• with known active central nervous system metastases (CNS) and/or cancerous meningitis;
• Any component of a product or preparation similar to the study drug PD-1 monoclonal antibody has ever caused a severe allergic reaction, including known severe allergic reaction to other monoclonal antibodies, oxaliplatin, S-1 and other related compounds (NCI-CTCAE V5.0≥3);
• a known history of hereditary bleeding or a blood clotting disorder that is at risk of bleeding;
• Patients who underwent major surgery within 4 weeks;
• Subjects who did not recover from complications from previous surgery, i.e., did not drop to ≤1 (CTCAE version 5.0) (excluding hair loss and fatigue);
• Immunosuppressive drugs should be used for 2 weeks or within 2 weeks or during the study, excluding the following situations:
• A) Intranasal, inhaled, topical or topical steroid injections (e.g. intraarticular); B) Systemic corticosteroids at physiological dose (≤10mg/day prednisone or equivalent); C) short-term (≤7 days) use of steroids to prevent or treat non-autoimmune allergic diseases;
• Subjects with active or preexisting autoimmune diseases that are likely to recur;

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

RECRUITING

MeSH Terms

Interventions

apatinib

Study Officials

• Chengxue Dang, PhD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chengxue Dang, PhD

CONTACT

0086-13319202569; dangchengxue@mail.xjtu.edu.cn

Peng Xia, PhD

CONTACT

0086-18991232542

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 11, 2021
• Study Start: January 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)