Nimotuzumab Combined With GX As Postoperative Adjuvant Therapy In Pancreatic Cancer

Study Overview

Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer

This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with GX for postoperative adjuvant treatment of pancreatic cancer.

This clinical study is designed as a prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy and safety of Nimotuzumab combined with GX (gemcitabine plus capecitabine) compared with GX only for resected pancreatic cancer. About 146 patients will be enrolled in this study and randomly divided into experimental group (nimotuzumab plus GX) and control group (placebo plus GX) at a ratio of 1:1. The main endpoint is relapse-free survival (RFS). Additional end points included distant metastasis-free survival (DMFS), overall survival (OS), tumor-related markers and safety.

Pancreatic Cancer

DRUG: Nimotuzumab
DRUG: GX
DRUG: Placebo

IST-Nim-PC-45

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-05-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-05-07
First Submitted that Met QC Criteria 2024-05-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-05-10
First Posted (ACTUAL) 2024-05-10	Results First Posted N/A	Last Verified 2024-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Experimental group (Nimotuzumab+ GX)	DRUG: Nimotuzumab Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600 mg on Day 1 and 8 of a 21-day cycle, up to 6 months. DRUG: GX Patients will receive GX as adjuvant therapy for 6 months. Gemcitabine will be delivered as a 1000 mg/m² intravenous infusion administered on Day 1 and 8 of a 21-day cycle. Capecitabine 2000mg/m²/day will be administered orally for 14 days followed by 7 d
PLACEBO_COMPARATOR: Control group (Placebo+ GX)	DRUG: GX Patients will receive GX as adjuvant therapy for 6 months. Gemcitabine will be delivered as a 1000 mg/m² intravenous infusion administered on Day 1 and 8 of a 21-day cycle. Capecitabine 2000mg/m²/day will be administered orally for 14 days followed by 7 d DRUG: Placebo Patients will receive placebo 400 mg weekly or placebo 600 mg on Day 1 and 8 of a 21-day cycle, up to 6 months.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Experimental group (Nimotuzumab+ GX)

DRUG: Nimotuzumab

Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600 mg on Day 1 and 8 of a 21-day cycle, up to 6 months.

DRUG: GX

Patients will receive GX as adjuvant therapy for 6 months. Gemcitabine will be delivered as a 1000 mg/m² intravenous infusion administered on Day 1 and 8 of a 21-day cycle. Capecitabine 2000mg/m²/day will be administered orally for 14 days followed by 7 d

PLACEBO_COMPARATOR: Control group (Placebo+ GX)

DRUG: GX

Patients will receive GX as adjuvant therapy for 6 months. Gemcitabine will be delivered as a 1000 mg/m² intravenous infusion administered on Day 1 and 8 of a 21-day cycle. Capecitabine 2000mg/m²/day will be administered orally for 14 days followed by 7 d

DRUG: Placebo

Patients will receive placebo 400 mg weekly or placebo 600 mg on Day 1 and 8 of a 21-day cycle, up to 6 months.

Primary Outcome Measures	Measure Description	Time Frame
relapse-free survival (RFS)	The time from the date of surgery to the disease recurrence or death, whichever is earlier.	Up to 24 months

Secondary Outcome Measures	Measure Description	Time Frame
distant metastasis-free survival (DMFS)	The time from the date of surgery to the first distant metastasis or death due to any cause, whichever is earlier.	Up to 24 months
overall survival (OS)	The time from the date of surgery to death due to any cause.	Up to 24 months
tumor-related markers	To explore the influence of tumor-related markers (such as KRAS, EGFR) on prognosis.	Up to 24 months
adverse events	Frequency and severity of adverse events	Up to 30 days after last administration.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Chuntao Gao, Dr

Phone Number: 022-2340123

Email: gaochuntao@tjmuch.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

1. Able and willing to provide a written informed consent.
2. Age 18-75 years old, gender unlimited;
3. Histologically or cytologically confirmed resected pancreatic ductal adenocarcinoma (PDAC), resectable evaluation is based on criteria of NCCN guidelines, no evidence of distant metastasis as demonstrated by imaging;
4. Postoperative pathology suggested R0/R1 resection;
5. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10^9/L; platelets≥100×10^9/L; hemoglobin≥9.0 g/dL; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN or estimated creatinine clearance > 60 mL/min;
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
7. Postoperative survival is expected to be ≥3 months;
8. Fertile subjects are willing to take contraceptive measures during the study period.

1. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma;
2. Accompanied by other serious diseases, including but not limited to: active infections; unmanageable diabetes mellitus and uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg); compensatory heart failure (NYHA grade III and IV), unstable angina or poorly controlled arrhythmias within 3 months prior to randomization; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency and Severe lung disease; Central Nervous System Disease or mental illness;
3. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
4. bleeding or clotting disorder;
5.Postoperative complications such as bleeding, pancreatic fistula, gastric obstruction, abdominal infection, and biliary fistula, which made the patient unable to receive adjuvant therapy within 12 weeks after surgery;
6. Known allergy to prescription or any component of the prescription used in this study;
7. Factors that significantly affect oral drug absorption, such as dysphagia, chronic diarrhea, gastrointestinal obstruction, etc;
8. Known HIV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);
9.Other reasons that are not suitable to participate in this study according to the researcher's judgment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Jihui Hao, Dr, Tianjin Medical University Cancer Institute and Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record