Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Brief Summary

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This is an open label, multicenter, single-arm phase II trial with primary eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with resectable, histologically proven gastric or esophageal cancer.

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Detailed Description

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Conditions

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KRAS Wild Type Resectable Type II Gastric Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment

3 cycles(repeated q21d) Epirubicine 50mg/m² i.v. d1 Oxaliplatin 100mg/m² i.v. d1 Capecitabine 500mg/m² bid d1-d21 Panitumumab 9mg/kg i.v. d1

Group Type EXPERIMENTAL

Epirubicine, Oxaliplatin, Capecitabine, Panitumumab

Intervention Type DRUG

3 cycles (repeated q 21d) Epirubicine 50mg/m² i.v. d1 Oxaliplatin 100mg/m² i.v. d1 Panitumumab 9mg/kg i.v. d1 Capecitabine 500mg/m² bid d1-21

Interventions

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Epirubicine, Oxaliplatin, Capecitabine, Panitumumab

3 cycles (repeated q 21d) Epirubicine 50mg/m² i.v. d1 Oxaliplatin 100mg/m² i.v. d1 Panitumumab 9mg/kg i.v. d1 Capecitabine 500mg/m² bid d1-21

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Untreated, histologically confirmed, KRAS wild type, resectable gastric or esophageal adenocarcinoma
* T2-4 NX M0 disease
* ECOG performance status 0-1
* adequate hematological status
* adequate renal function
* adequate hepatic function
* adequate metabolic function

Exclusion Criteria

* pregnant or breast feeding women
* previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
* arterial or venous thromboembolism within 6 months before enrollment
* clinically significant cardiovascular disease within 1 year before enrollment
* history of interstitial lung disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No