Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07438106

A Phase II Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-04-15

30

Participants Needed

1

Research Sites

96 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will evaluate the effectiveness and safety of HRS-4642 in combination with nab-paclitaxel and gemcitabine (AG regimen) as conversion therapy for patients with locally advanced pancreatic cancer. Participants will undergo regular assessments, including imaging scans and CA19-9 biomarker tests. If disease recurrence is suspected, unscheduled evaluations may be performed. For participants who discontinue treatment due to reasons other than disease progression (e.g., toxicity), tumor assessments will continue as scheduled until progression, loss to follow-up, death, consent withdrawal, or study termination. After the final treatment, participants will enter a survival follow-up phase. Investigators will contact the participants or their families approximately every month (±7 days) to collect information on survival status (date and cause of death) and any subsequent anti-cancer treatments until death, loss to follow-up, study termination, or other study endpoints are met. All follow-up information will be documented in the medical records.

CONDITIONS

Official Title

A Phase II Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years, any gender
  • Confirmed diagnosis of pancreatic ductal adenocarcinoma by biopsy or cytology
  • Locally advanced pancreatic cancer without distant metastasis, with specific tumor involvement of arteries or veins
  • Confirmed KRAS G12D mutation by tissue or blood testing
  • ECOG performance status of 0 or 1
  • No previous cancer treatments including chemotherapy, radiotherapy, targeted or immunotherapy
  • At least one measurable tumor lesion by imaging criteria
  • If biliary obstruction is present, it must be relieved before study entry and expected survival greater than 3 months
  • Signed informed consent before any study procedures
  • Adequate organ function based on blood tests and ECG within specified limits before treatment
  • Female participants of childbearing potential must have a negative pregnancy test and agree to use contraception; males with partners of childbearing potential must also agree to contraception
Not Eligible

You will not qualify if you...

  • Presence of portal hypertension or severe tumor involvement causing bleeding, fistula, abscess, or artery encasement
  • Other cancers diagnosed within 5 years except certain skin cancers
  • Active autoimmune disease requiring systemic therapy in past 2 years
  • Use of systemic corticosteroids or immunosuppressive therapy within 7 days before treatment (except low-dose corticosteroids)
  • History of organ or stem cell transplant (except corneal transplant)
  • Significant allergy or hypersensitivity to study treatments
  • Acute or chronic pancreatitis
  • History of drug abuse, chronic alcoholism, or infectious diseases like HIV
  • Uncontrolled active hepatitis B or active hepatitis C infection
  • Recent live attenuated vaccine within 28 days before treatment
  • Recent major surgery within 28 days or minor surgery within 7 days before treatment
  • Severe or uncontrolled systemic diseases including certain heart, lung, liver, infectious, or vascular conditions
  • Severe infection requiring hospitalization or intravenous antibiotics within 28 days before treatment
  • Any condition or abnormal test results judged by the investigator to interfere with the study or participant safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Jiangsu Province Hospital

Nanjing, China

Actively Recruiting

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Research Team

J

Jiang KUIRONG

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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