Clinical trial · Interventional
Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
NCT05111444CI-TRIAL-00054923unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to evaluate the efficacy and safety of Camrelizumab plus pyrotinib in combination with chemotherapy in patients with HER2-positive gastric cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Neoplasms | Gastric Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pyrotinib | Drug | Pyrotinib | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Camrelizumab+Pyrotinib + Chemotherapy
- description
- Camrelizumab (200 mg) will be administered intravenously \[IV\] on day 1 of each 3-week cycle. Pyrotinib (320 mg) will be administered orally once daily \[QD\] on every 21 days. Chemotherapy will either be XELOX, SOX or TS.
- interventionNames
- Drug: Camrelizumab
- Drug: Pyrotinib
- Drug: Capecitabine
- Drug: Oxaliplatin
- Drug: Paclitaxel
- Drug: S-1
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- [ Time Frame: Up to approximately 2 years ]
- description
- Objective response rate assessed at 18 weeks after enrollment,that is about 6 cycles of treatment
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or older. 2. Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma. 3. Patients have not received systemic treatment in the past but had disease progression more than 6 months after receiving neoadjuvant therapy or the last of adjuvant therapy could be enrolled or failure of first-line therapy or completion of (new) adjuvant therapy to disease recurrence less than 6 months. 4. HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with fluorescent in-situ hybridization (FISH+ is defined as HER2:CEP17 ratio≥2.0), as assessed by central review on primary or metastatic tumor. 5. ECOG performance status 0-1. 6. At least one measurable lesion exists as defined by RECIST 1.1 . 7. Life expectancy of more than 12 weeks. Exclusion Criteria: 1. Hypersensitivity to Camrelizumab, pyrotinib and study chemotherapy agents and/or to any components. 2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX 40, Cluster of Differentiation 137 \[CD137\]). 3. Has an active autoimmune disease that has required systemic treatment in past 2 years. 4. Has a known history of Human Immunodeficiency Virus (HIV) or active hepatitis B and C virus infection. 5. Has had major surgery within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment. 6. Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study. 7. Evidence or history of coagulation disorders such as a grade ≥ 3 (CTC-AE) bleeding event. 8. Known history of psychotropic substance abuse or drug use.
References
Publications (0)
Data not yet available
No reference posted for this study.