Clinical trial NCT06409429: Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
Official title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pancreatic Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: relapse-free survival (RFS)
timeFrame: Up to 24 months
Secondary outcomes:
measure: distant metastasis-free survival (DMFS)
timeFrame: Up to 24 months
measure: overall survival (OS)
timeFrame: Up to 24 months
measure: tumor-related markers
timeFrame: Up to 24 months
measure: adverse events
timeFrame: Up to 30 days after last administration.
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Jihui Hao, Dr
role: STUDY_CHAIR
References: