Promising new drug cocktail targets tough pancreatic cancer
NCT ID NCT07277452
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding nimotuzumab, a targeted antibody, to standard chemotherapy can help people with high-risk pancreatic cancer that can still be surgically removed. About 156 participants will receive either the drug combo or a placebo before and after surgery. The main goal is to see if it delays cancer recurrence.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nimotuzumab (a targeted antibody) combined with nab-paclitaxel and gemcitabine (chemotherapy)
- What this could lead to
- If it works, this could offer a more effective treatment option for people with high-risk pancreatic cancer, potentially delaying recurrence and extending survival.
- What could go wrong
- This is an early phase 2 trial with only 156 participants. The drug may not improve outcomes over standard care, and side effects from the combination could be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 156 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Dec 2025
An estimate. Start dates often move.
- Expected to finish
-
Dec 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Age 18-75 years old, gender unlimited; * 2\. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC); * 3\. Confirmed as resectable/borderline resectable pancreatic cancer by CT/MRI imaging (resectability assessment refers to NCCN guidelines). For resectable pancreatic cancer, at least one of the following high-risk factors must be met: 1) CA199 \> 500 U/ml; 2) the maximum diameter of the primary tumor \> 3.0 cm; 3) Severe weight loss (BMI \< 18.5 kg/m² OR involuntary weight loss \> 15% within 6 months); 4) Severe pain (Numeric Rating Scale \[NRS\]≥ 4); 5) Definite regional lymph node metastasis (N1 or N2) OR suspicious regional lymph node metastasis (short-axis diameter of lymph nodes ≥15 mm); * 4\. Voluntarily agree to sample collection (for KRAS gene testing and post-hoc analysis); * 5\. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10\^9/L; platelets≥80×10\^9/L; 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 (PS) 0-2; * 7\. Life expectancy of at least 3 months; * 8\. Women of childbearing age should have a negative result of serum HCG or urine pregnancy tests within 72 hours prior to randomization (Postmenopausal women who have had amenorrhea for at least 12 months are considered sterile and women known to have had tubal ligation are not required to undergo pregnancy tests) ; * 9\. Good compliance and signed informed consent. Exclusion Criteria: * 1\. Previous treatment for pancreatic cancer. * 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; digestive tract obstruction; respiratory insufficiency and severe lung disease; central nervous system disease or mental illness; * 3\. Clinically diagnosed as local recurrence of pancreatic cancer, or there is evidence of peritoneal/other distant metastases; * 4.History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); * 5\. Presence of bleeding or coagulation disorders; * 6\. Known allergy to prescription or any component of the prescription used in this study; * 7\. Known HIV infection, syphilis infection, or active hepatitis (hepatitis B or C); * 8\. Women who are pregnant or are breastfeeding; * 9.Other reasons that are not suitable to participate in this study according to the researcher's judgment.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pancreatic cancer, adult are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Chunyi Hao
Beijing, 100000, China
-
Kuirong Jiang
Nanjing, Jiangsu, 210029, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can digital questionnaires improve life during pancreatic cancer therapy?
- Can a phone app help pancreatic cancer patients eat better during treatment?
- Can a Dietitian's plan help older pancreatic cancer patients feel better?
- Can a vaccine stop GI cancers from returning?
- Triple therapy aims to stall pancreatic cancer
- Can removing more tissue around pancreatic tumors stop cancer from coming back?