Clinical trial NCT05111444: Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Official title: Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Neoplasms
Gastroesophageal Junction Adenocarcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: [ Time Frame: Up to approximately 2 years ]
Secondary outcomes:
measure: Progression Free Survival (PFS) per RECIST 1.1 assessed by BICR
timeFrame: [ Time Frame: Up to approximately 2 years ]
measure: Overall Survival (OS)
timeFrame: [ Time Frame: Up to approximately 2 years ]
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 270 Dongan Road, Fudan University Shanghai Cancer Center
Study officials:
References: