Active — Not RecruitingPhase 1/2

HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma

China20 participantsStarted 2025-02-10

Plain-language summary

To evaluate the safety and efficacy of HRS-4642 combined with Nimotuzumab in patients with recurrent or metastatic pancreatic ductal adenocarcinoma.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and female subjects aged 18-75 years (including 18 and 75 years).
. Pancreatic ductal adenocarcinoma confirmed by pathology (histology) or cytology.
. Patients with metastatic pancreatic ductal adenocarcinoma.
. At the time of study enrollment, according to the solid tumor efficacy evaluation criteria (RECIST1.1), imaging diagnosis had at least one measurable lesion (lesion diameter ≥10 mm and lymph node diameter ≥15 mm according to CT or MRI evaluation).
. Physical condition score ECOG score 0-2 points.
. Expected survival ≥ 12 weeks.
. Major organ function is normal.
. The AE caused by previous anti-tumor therapy must be restored to the level of ≤ grade 1 (CTCAE v5.0) or the level specified in the inclusion criteria. If the investigator determines that NCI-CTCAE≤ grade 2 and there is no safety risk to the subject, the participant can be enrolled, such as receiving immune checkpoint inhibitor therapy. Subjects with type 1 diabetes and hypothyroidism that are stable after hormone replacement therapy.

Exclusion criteria

. The patient had previously used KRAS inhibitors or targeted EGFR therapy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

RP2D

Timeframe: Approximately 12 months

ORR

Timeframe: Approximately 12 months

Trial details

NCT IDNCT06773130

SponsorWest China Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

View on ClinicalTrials.gov More Pancreatic Ductal Adenocarcinoma (PDAC) trials