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

Yanqiao Zhang

Status and phase: Unknown; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Oxaliplatin; Drug: S-1; Drug: Albumin-bound paclitaxel; Drug: Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT03825328

HZ-NS/GEMOX-PC

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Chemotherapy

Experimental group

Description:

Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles

Treatment:

Drug: Gemcitabine

Drug: Oxaliplatin

Drug: S-1

Drug: Albumin-bound paclitaxel