---
title: Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer
nct_id: NCT06722911
overall_status: RECRUITING
phase: PHASE2
sponsor: "Zhejiang Provincial People's Hospital"
study_type: INTERVENTIONAL
primary_condition: Pancreatic Cancer Resectable
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06722911.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06722911"
ct_last_update_post_date: 2024-12-09
last_seen_at: "2026-05-12T07:21:21.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of Adjuvant Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine in EGFR-positive Pancreatic Cancer

**Official Title:** Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine As Postoperative Adjuvant Therapy in Patients with EGFR-positive Pancreatic Cancer: a Prospective, Single-arm Study

**NCT ID:** [NCT06722911](https://clinicaltrials.gov/study/NCT06722911)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 57
- **Lead Sponsor:** Zhejiang Provincial People's Hospital
- **Conditions:** Pancreatic Cancer Resectable
- **Start Date:** 2024-11-15
- **Completion Date:** 2028-09-30
- **CT.gov Last Update:** 2024-12-09

## Brief Summary

This is a prospective, single-arm trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with nab-paclitaxel+ gemcitabine (AG regimen) for postoperative adjuvant treatment of pancreatic cancer with EGFR-positive.

## Detailed Description

This clinical study is designed as a prospective, open-label, single arm, phase II study to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG (nab-paclitaxel+ gemcitabine) as postoperative adjuvant therapy in patients with EGFR-positive pancreatic cancer. The main endpoint is disease-free survival (DFS). Additional end points included distant metastasis-free survival (DMFS), overall survival (OS), tumor-related markers and safety.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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\. EGFR positive (by immunohistochemistry);
* 6\. KRAS gene and CDX-2 protein status must have been determined at baseline (only for post hoc analysis);
* 7\. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10\^9/L; platelets≥80×10\^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;
* 8\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* 9\. Postoperative survival is expected to be ≥3 months;
* 10\. 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\. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* 3\. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP\>160mmHg or DBP\>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
* 4\. 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;
* 5\. CA199\>180 U/ml within 21d before adjuvant therapy;
* 6\. Known allergy to prescription or any component of the prescription used in this study;
* 7\. Known HIV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C);
* 8 .Other reasons that are not suitable to participate in this study according to the researcher\'s judgment.
```

## Arms

- **Nimotuzumab+ AG** (EXPERIMENTAL)

## Interventions

- **Nimotuzumab** (DRUG) — Nimotuzumab 400 mg on Day 1 and 15 of a 28-day cycle (6 cycles) ; Patients will receive Nimotuzumab 600 mg on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity.
- **AG** (DRUG) — Patients will receive nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1,000 mg/m\^2 as one intravenous infusion over 30-40 minutes on days 1 and 8 of every 21-day cycle. Patients will receive six treatment cycles unless there is radiologic evidence of disease recurrence and unacceptable toxicity.

## Primary Outcomes

- **disease-free survival (DFS)** _(time frame: Up to 24 months)_ — The time from the date of surgery to the disease recurrence or death, whichever is earlier.

## Secondary Outcomes

- **distant metastasis-free survival (DMFS)** _(time frame: Up to 24 months)_
- **overall survival (OS)** _(time frame: Up to 24 months)_
- **tumor-related markers** _(time frame: Up to 24 months)_
- **adverse events** _(time frame: Up to 30 days after last administration)_

## Locations (1)

- Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.zhejiang provincial people's hospital|hangzhou|zhejiang|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06722911*  
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