Nimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer

NCT06409429 | Not Yet Recruiting Phase 2

• 1 other identifier: IST-Nim-PC-45
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• distant metastasis-free survival (DMFS)

  Up to 24 months

• overall survival (OS)

  Up to 24 months

• tumor-related markers

  Up to 24 months

• adverse events

  Up to 30 days after last administration.

Study Arms (2)

Experimental group (Nimotuzumab+ GX)

EXPERIMENTAL

Drug: Nimotuzumab; Drug: GX

Control group (Placebo+ GX)

PLACEBO COMPARATOR

Drug: GX; Drug: Placebo

Interventions

Nimotuzumab DRUG

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.

Also known as: h-R3

Experimental group (Nimotuzumab+ GX)

GX DRUG

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 days' rest.

Control group (Placebo+ GX); Experimental group (Nimotuzumab+ GX)

Placebo DRUG

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.

Control group (Placebo+ GX)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Able and willing to provide a written informed consent.
• \. Age 18-75 years old, gender unlimited;
• \. 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;
• \. Postoperative pathology suggested R0/R1 resection;
• \. 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;
• \. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• \. Postoperative survival is expected to be ≥3 months;
• \. Fertile subjects are willing to take contraceptive measures during the study period.

You may not qualify if:

• \. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma;
• \. 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;
• \. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• \. bleeding or clotting disorder;
• 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;
• \. Known allergy to prescription or any component of the prescription used in this study;
• \. Factors that significantly affect oral drug absorption, such as dysphagia, chronic diarrhea, gastrointestinal obstruction, etc;
• \. Known HIV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);
• Other reasons that are not suitable to participate in this study according to the researcher's judgment

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jihui Hao, Dr

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Central Study Contacts

Chuntao Gao, Dr

CONTACT

022-2340123; gaochuntao@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)