A Trial of NS/GEMOX Chemotherapy in Patients With Untreated Pancreatic Cancer ( HZ-NS/GEMOX-PC )

Phase 2

• Conditions: Pancreatic Cancer
• Interventions: Drug: Albumin-bound paclitaxel; Drug: S-1; Drug: Oxaliplatin; Drug: Gemcitabine

• Registration Number: NCT03825328
• Lead Sponsor: Yanqiao Zhang

Brief Summary

This is a Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With untreated Pancreatic cancer.

This study aims to evaluate the safety and efficacy of Sequential GEMOX/NS Chemotherapy as a first-line treatment of untreated Pancreatic cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study Start: 2019-01-30
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Last Update Submitted: 2019-01-30
• Study First Posted: 2019-01-31
• Last Update Posted: 2019-01-31
• Primary Completion: 2020-01-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Voluntarily participate in the trial and sign the informed consent form
2. 18 years old <age <75 years old
3. Histopathological or cytologically confirmed (inoperable) locally advanced or recurrent metastatic pancreatic ductal adenocarcinoma with lesions measurable according to RECIST criteria
4. ECOG score 0-1
5. Life expectancy > 3 months
6. There must be a CT or MRI examination within a week
7. at least one lesion that can be measured by the RECIST v1.1 standard
8. No chemotherapy has been performed (the interval between postoperative adjuvant chemotherapy must be more than 6 months)
9. without radiation therapy (unless there is at least one measurable target lesion in the non-irradiated area)

Exclusion Criteria

1. pregnant or lactating women; or those who have fertility but refuse to take contraceptive measures;
2. Severe active infections requiring intravenous antibiotic treatment during enrollment;
3. those who are allergic to the test drug;
4. There is ≥2 neuropathy (CTCAE 4.0);
5. uncontrolled, symptomatic brain metastases or those with a history of uncontrollable psychiatric disorders; severe intellectual or cognitive dysfunction;
6. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack;
7. Have other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin that has been basically controlled;
8. Patients who are unable to follow the protocol or who are unable to follow up;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Albumin-bound paclitaxel	Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles
Chemotherapy	Gemcitabine	Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles
Chemotherapy	Oxaliplatin	Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles
Chemotherapy	S-1	Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles

Primary Outcome Measures

Name	Time	Method
PFS	from the first drug administration up to 6 months	progression-free survival
OS	from the first drug administration up to 1 year	overall survival