Rimegepant Combined With AG Chemotherapy As First-Line Treatment For Metastatic Pancreatic Ductal Adenocarcinoma

ConditionMetastatic Pancreatic Ductal Adenocarcinoma

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorXiuchao Wang

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient has good compliance, understands the study procedures, and has signed a written informed consent form.

Age ≥ 18 years.

Pathologically or cytologically confirmed pancreatic cancer, with imaging or pathological findings indicating unresectable pancreatic cancer with distant metastasis.

Patients who have not received any prior treatment for pancreatic cancer (including radiotherapy, chemotherapy, or experimental therapy), except for surgical resection.

Disqualifiers

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.

Patients diagnosed with pulmonary fibrosis or interstitial pneumonia within 28 days prior to enrollment.

Patients with refractory pleural effusion or ascites.

Patients with known brain or meningeal metastases.

Trial design

Design model

Single group

Treatments tested in this trial

Rimegepant plus Nab-Paclitaxel and Gemcitabine
Drug
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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Single-ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

From randomization to disease progression or death, with follow-up for up to 2 years after treatment initiation.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiuchao Wang

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: