RecruitingPhase 2NCT05585580

Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy

Efficacy and Safety of Serplulimab, Lenvatinib, and Paclitaxel in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma After First-line Immunotherapy: a Prospective, Single-armed Clinical Trial


Sponsor

Qilu Hospital of Shandong University

Enrollment

59 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single arm, multicenter phase II study to assess the effectiveness of Serplulimab, Lenvatinib and Paclitaxel in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma after first-line immunotherapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a 3-drug combination — serplulimab (immunotherapy), lenvatinib (a targeted therapy), and paclitaxel (chemotherapy) — as a second-line treatment for people with advanced stomach or gastroesophageal junction cancer who previously received immunotherapy as their first treatment. **You may be eligible if...** - You are 18–75 years old - You have confirmed advanced gastric or gastroesophageal junction cancer - Your cancer either has a PD-L1 score of 1 or higher, OR you previously responded well to immunotherapy (with progression-free survival of 6+ months) - Your previous treatment side effects have mostly resolved - Your cancer can be measured on scans - You can provide a tissue sample **You may NOT be eligible if...** - You have not previously received immunotherapy - Your cancer progressed very quickly on prior immunotherapy - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSerplulimab

300mg d1 q3w

DRUGLenvatinib

8mg po qd

DRUGPaclitaxel/Paclitaxel-albumin/Paclitaxel liposome

135\~175mg/m2 /260mg/m2/135-175mg/m2 d1 q3w


Locations(7)

Qilu hospital of Shandong univertisy

Jinan, Shandong, China

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Qingdao Municipal Hospital(Group)

Qingdao, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Linyi Cancer Hospital

Linyi, China

View Full Details on ClinicalTrials.gov

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NCT05585580


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