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EGFR Monoclonal Antibody for Advanced Gastric Cancer

NCT ID: NCT04136600

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-12-31

Brief Summary

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This study is intended to evaluate efficacy and safety of EGFR monoclonal antibody (Cetuximab/Nimotuzumab) in combination with a chemotherapy in gastric cancer patients with EGFR amplification.

Detailed Description

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This parallel, randomized, open-label, single-centre study will evaluate the effect on overall survival of EGFR monoclonal antibody (Cetuximab/Nimotuzumab) in combination with a chemotherapy compared to the chemotherapy alone in patients with EGFR-amplication advanced gastric cancer. Cetuximab will be administered as intravenous infusion of 500 mg/m2 (BSA) every 3 weeks, while nimotuzumab will be administered as intravenous infusion of 400mg every week. The chemotherapy consists of a combination of 12 cycles of mFOLFOX-6, 6-8 cycles of SOX, 6-8 cycles of CapOX. Treatment with cetuximab/nimotuzumab will continue until disease progression. The target sample size is 50-100 patients.

Conditions

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Gastric Cancer Cetuximab Nimotuzumab

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EGFR antibody arm

Participants received a dose of 500 mg/m2 Cetuximab iv on Day 1 of cycle every 3 weeks, or 400mg Nimotuzumab on Day 1 of cycle, every week, until disease progression. 12 cycles of mFOLFOX (5-fluorouracil (5-FU) 1,200 mg/m2/day for 46 hours, leucovorin 200 mg/m2, and oxaliplatin 85 mg/m2 biweekly). 6-8 cycles of CapOX (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks + oxaliplatin 135mg/m2 every 3 weeks). 6-8 cycles of SOX (S-1, 60mg for BSA\>1.5, 50 mg for 1.5\>BSA\>1.25 , 40mg for BSA\<1.25 po twice daily for 14 days every 3 weeks + oxaliplatin 135mg/m2 every 3 weeks)

Group Type EXPERIMENTAL

EGFR antibody and Chemotherapy

Intervention Type DRUG

Drug: Cetuximab Cetuximab: 500 mg/m2 iv on Day 1 of cycle every 3 weeks, until disease progression.

Other Names:

Erbitux Drug: Nimotuzumab Nimotuzumab: 400mg iv on Day 1 of cycle, every week, until disease progression

Drug: Fluoropyrimidine 5-fluorouracil (5-FU): 2,400 mg/m2/day iv in first 46 hours of cycle, every two weeks for 12 cycles

Other Names:

5-Fu Drug: Capecitabine Capecitabine: 1000 mg/m2 po twice daily for 14 days every 3 weeks, for 6 cycles

Other Names:

Xeloda Drug: S-1 S-1: 60mg for BSA\>1.5, 50 mg for 1.5\>BSA\>1.25 , 40mg for BSA\<1.25 po twice daily for 14 days every 3 weeks, for 6 cycles

Other Names:

S-1 Drug: Oxaliplatin Oxaliplatin: 85 mg/m2 iv on Day 1 of cycle, every 2 week for 12 cycles with 5-Fu; Oxaplatin: 130 mg/m2 iv on Day 1 of cycle, every 3 week for 6 cycles combined with S-1 or Capecitabine;

Placebo arm

12 cycles of mFOLFOX (5-fluorouracil (5-FU) 1,200 mg/m2/day for 46 hours, leucovorin 200 mg/m2, and oxaliplatin 85 mg/m2 biweekly). 6-8 cycles of CapOX (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks + oxaliplatin 135mg/m2 every 3 weeks). 6-8 cycles of SOX (S-1, 60mg for BSA\>1.5, 50 mg for 1.5\>BSA\>1.25 , 40mg for BSA\<1.25 po twice daily for 14 days every 3 weeks + oxaliplatin 135mg/m2 every 3 weeks)

Group Type PLACEBO_COMPARATOR

Chemotherapy

Intervention Type DRUG

Drug: Fluoropyrimidine 5-fluorouracil (5-FU): 2,400 mg/m2/day iv in first 46 hours of cycle, every two weeks for 12 cycles

Other Names:

5-Fu Drug: Capecitabine Capecitabine: 1000 mg/m2 po twice daily for 14 days every 3 weeks, for 6 cycles

Other Names:

Xeloda Drug: S-1 S-1: 60mg for BSA\>1.5, 50 mg for 1.5\>BSA\>1.25 , 40mg for BSA\<1.25 po twice daily for 14 days every 3 weeks, for 6 cycles

Other Names:

S-1 Drug: Oxaliplatin Oxaliplatin: 85 mg/m2 iv on Day 1 of cycle, every 2 week for 12 cycles with 5-Fu; Oxaplatin: 130 mg/m2 iv on Day 1 of cycle, every 3 week for 6 cycles combined with S-1 or Capecitabine;

Interventions

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Chemotherapy

Drug: Fluoropyrimidine 5-fluorouracil (5-FU): 2,400 mg/m2/day iv in first 46 hours of cycle, every two weeks for 12 cycles

Other Names:

5-Fu Drug: Capecitabine Capecitabine: 1000 mg/m2 po twice daily for 14 days every 3 weeks, for 6 cycles

Other Names:

Xeloda Drug: S-1 S-1: 60mg for BSA\>1.5, 50 mg for 1.5\>BSA\>1.25 , 40mg for BSA\<1.25 po twice daily for 14 days every 3 weeks, for 6 cycles

Other Names:

S-1 Drug: Oxaliplatin Oxaliplatin: 85 mg/m2 iv on Day 1 of cycle, every 2 week for 12 cycles with 5-Fu; Oxaplatin: 130 mg/m2 iv on Day 1 of cycle, every 3 week for 6 cycles combined with S-1 or Capecitabine;

Intervention Type DRUG

EGFR antibody and Chemotherapy

Drug: Cetuximab Cetuximab: 500 mg/m2 iv on Day 1 of cycle every 3 weeks, until disease progression.

Other Names:

Erbitux Drug: Nimotuzumab Nimotuzumab: 400mg iv on Day 1 of cycle, every week, until disease progression

Drug: Fluoropyrimidine 5-fluorouracil (5-FU): 2,400 mg/m2/day iv in first 46 hours of cycle, every two weeks for 12 cycles

Other Names:

5-Fu Drug: Capecitabine Capecitabine: 1000 mg/m2 po twice daily for 14 days every 3 weeks, for 6 cycles

Other Names:

Xeloda Drug: S-1 S-1: 60mg for BSA\>1.5, 50 mg for 1.5\>BSA\>1.25 , 40mg for BSA\<1.25 po twice daily for 14 days every 3 weeks, for 6 cycles

Other Names:

S-1 Drug: Oxaliplatin Oxaliplatin: 85 mg/m2 iv on Day 1 of cycle, every 2 week for 12 cycles with 5-Fu; Oxaplatin: 130 mg/m2 iv on Day 1 of cycle, every 3 week for 6 cycles combined with S-1 or Capecitabine;

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients \>=18 years of age
* Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction Adenocarcinoma
* EGFR-Amplification tumors (Copy Number\>=5 for tissue or blood Next Generation Sequence)
* Expected survival ≥ 3 month;
* ECOG / PS score: 0-2;
* the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min;

Exclusion Criteria

* Previous chemotherapy for advanced/metastatic disease;
* Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome;
* History of cardiac disease;
* Dyspnoea at rest, due to complications of advanced malignancy or other disease, or patients who require supportive oxygen therapy;
* Patient can not comply with research program requirements or follow-up;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Changzheng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuan-Sheng Zang

Department Head

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Medical Oncology, Shanghai Changzheng Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xiaodong Jiao

Role: primary

Other Identifiers

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EGFR-GC

Identifier Type: -

Identifier Source: org_study_id