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

Conditions

• Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Serplulimab — DRUG
  300mg d1 q3w
• Lenvatinib — DRUG
  8mg po qd
• Paclitaxel/Paclitaxel-albumin/Paclitaxel liposome — DRUG
  135\~175mg/m2 /260mg/m2/135-175mg/m2 d1 q3w

Study Details

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.

Key Dates

Start date

Mar 1, 2023

Status verified

Apr 2026

Primary completion

Apr 30, 2026

Completion

Nov 1, 2026

Study Design

Enrollment

59 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Serplulimab, lenvatinib and paclitaxel/Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposome
  Patients will be treated with serplulimab combined with lenvatinib and paclitaxel/ Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposomefor 6 cycles, followed by serplulimab combined with lenvatinib maintenance therapy until disease progression, intolerable adverse reactions, or withdrawal of treatment consent.

Primary Outcome Measure

Objective response rate （ORR) [ Time Frame: 6 months after the last subject participating in ]