Rimegepant Combined With AG Chemotherapy As First-Line Treatment For Metastatic Pancreatic Ductal Adenocarcinoma (RAG-MPDAC)

A Phase Ib/II Single-Arm, Single-Center, Prospective Clinical Study Of Rimegepant Combined With AG Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

This study aims to evaluate the efficacy and safety of Rimegepant combined with AG chemotherapy as first-line treatment for metastatic pancreatic cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Drug: Rimegepant plus Nab-Paclitaxel and Gemcitabine

Detailed Description

This is a single-center, single-arm, prospective Phase Ib/II study designed to evaluate the clinical efficacy and safety profile of Rimegepant in combination with the AG (Nab-paclitaxel plus Gemcitabine) chemotherapy regimen as first-line treatment for patients with unresectable metastatic pancreatic cancer who have not received prior anti-pancreatic cancer therapy (surgical resection excepted).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xiuchao W Chief Physician; Phone Number: +86 13752038814; Email: wangxiuchao2008@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The patient has good compliance, understands the study procedures, and has signed a written informed consent form.
2. Age ≥ 18 years.
3. Pathologically or cytologically confirmed pancreatic cancer, with imaging or pathological findings indicating unresectable pancreatic cancer with distant metastasis.
4. Patients who have not received any prior treatment for pancreatic cancer (including radiotherapy, chemotherapy, or experimental therapy), except for surgical resection.
5. If the patient has received neoadjuvant/adjuvant chemotherapy, the regimen must not contain AG, and the interval from the last administration to the diagnosis of recurrence must be >6 months, with no delayed toxicities.
6. The patient has at least one measurable lesion according to the RECIST 1.1 criteria.
7. ECOG performance status 0-1.
8. Expected survival >3 months.

9. Adequate organ function, defined as meeting the following criteria (blood tests to be completed within 14 days prior to enrollment):

   1. Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
   2. Hemoglobin ≥90 g/dL
   3. Platelet count (PLT) ≥100 × 10⁹/L
   4. Total bilirubin <1.5 × upper limit of normal (ULN)
   5. Liver transaminases (AST & ALT) <2.5 × ULN; for patients with liver metastases, AST/ALT ≤5 × ULN
   6. Serum creatinine ≤1 × ULN, or creatinine clearance ≥50 mL/min if serum creatinine >1 × ULN
10. The patient has an adequate nutritional status, defined as BMI >18.5 kg/m².
11. Female patients who are not pregnant or breastfeeding; sexually active men and women of childbearing potential must use effective contraception during the study and for 6 months after treatment completion.
12. No contraindications to remimazolam or AG chemotherapy agents.

Exclusion Criteria:

1. Patients with a history of other malignancies within the past 5 years, except for cured in situ carcinoma or basal cell carcinoma of the skin.
2. Patients diagnosed with pulmonary fibrosis or interstitial pneumonia within 28 days prior to enrollment.
3. Patients with refractory pleural effusion or ascites.
4. Patients with known brain or meningeal metastases.
5. Patients who used strong CYP3A4 inducers within 3 weeks prior to the first study drug administration, or strong CYP3A4/UGT1A1 inhibitors within 3 weeks prior to the first study drug administration.
6. Patients who underwent major organ surgery (excluding needle biopsy, central venous catheter insertion, port catheterization, biliary obstruction stenting, percutaneous transhepatic biliary drainage, and cholecystostomy) within 4 weeks prior to the first dose of study drug, or who plan to undergo elective surgery.
7. Patients with known dihydropyrimidine dehydrogenase deficiency or low activity.
8. Patients with active infection, including HIV infection, or chronic HBV/HCV in the active phase (HBV DNA ≥10⁴ copies/mL or ≥2000 IU/mL; patients must receive antiviral therapy first, and can only be enrolled when HBV DNA <10⁴ copies/mL or <2000 IU/mL, with continued antiviral therapy and monitoring of liver function and HBV viral load).
9. Patients with severe comorbidities, including poorly controlled diabetes despite anti-diabetic medication, clinically significant active heart disease, renal failure, liver failure, uncontrolled epilepsy, history of central nervous system disease or mental disorder, hemorrhagic peptic ulcer, ileus, or intestinal obstruction.
10. Patients with severe diarrhea (grade ≥2 per NCI-CTCAE v5.0: ≥4 bowel movements per day vs baseline; moderate/severe increase in stoma output; limitation of activities of daily living).
11. Patients with severe psychiatric disorders.
12. Patients with grade ≥II peripheral neuropathy at present or in the past.
13. Patients with known hypersensitivity to benzodiazepines, AG chemotherapy agents, or related components.
14. Patients who participated in other clinical trials within 4 weeks prior to enrollment.
15. Patients deemed unsuitable for the trial by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-Arm; Patients receive Rimegepant combined with AG chemotherapy as first-line treatment for metastatic pancreatic cancer, with assessment of efficacy and safety outcomes.	Drug: Rimegepant plus Nab-Paclitaxel and Gemcitabine; Rimegepant 75 mg every other day. Nab-paclitaxel 125 mg/m² and Gemcitabine 1000 mg/m² intravenously on Days 1 and 8 of a 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival	Time from randomization to disease progression or death from any cause, assessed per RECIST v1.1 and evaluated every 6 weeks during treatment and follow-up.	From randomization to disease progression or death, with follow-up for up to 2 years after treatment initiation.

Collaborators and Investigators

• Sponsor: Xiuchao Wang

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; 130-nm albumin-bound paclitaxel; rimegepant sulfate
• Other Study ID Numbers: E20260288

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No