At a glance
ClinicalIndex Comparison Record- ✓Age 18-75 years old
- ✓ECOG performance status 0-1
- ✓Histologically or cytologically confirmed gastric or GEJ carcinoma
- ✓Radical resection with D2 dissection and R0 or R1 margins
- ✕Participation in other drug trials within 4 weeks
- ✕Factors affecting oral absorption (inability to swallow, chronic diarrhea, intestinal obstruction)
- ✕Bleeding event grade ≥3 per CTCAE 5.0 within 4 weeks
- ✕CNS metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05494060Phase 2RecruitingUpdate OverdueUpdated 31mo ago · Completion was 18mo agoXELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma, a Randomized, Controlled, Multicenter Clinical Trial
In Brief
A Phase 2 clinical trial evaluating Anlotinib hydrochloride capsule, Penpulimab Injection, and 1 other intervention for Carcinoma and 6 related conditions. Currently recruiting, targeting 80 participants across 1 site.
Signals
Detailed Summary
This is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks/cycle) + XELOX and XELOX at a ratio of 1:1. This study is conducted to assess safety and anti-tumor activity of the monoclonal antibody Penpulimab in combination with Anlotinib and standard chemotherapy as adjuvant treatment for ctDNA-positive Gastric, or Gastroesophageal Junction Carcinoma.
Study Details
Timeline
Interventions
Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)；
Penpulimab Injection 100mg per bottle, 200mg IV Day 1, cycled every 21 days
Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w