Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Phase 2

• Conditions: Gastric Neoplasms; Gastroesophageal Junction Adenocarcinoma
• Interventions: Drug: Camrelizumab; Drug: Pyrotinib; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Paclitaxel; Drug: S-1

• Registration Number: NCT05111444
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08
• Study Start: 2021-12-31
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Camrelizumab+Pyrotinib + Chemotherapy	Camrelizumab	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.
Camrelizumab+Pyrotinib + Chemotherapy	Pyrotinib	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.
Camrelizumab+Pyrotinib + Chemotherapy	Capecitabine	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.
Camrelizumab+Pyrotinib + Chemotherapy	Paclitaxel	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.
Camrelizumab+Pyrotinib + Chemotherapy	S-1	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.
Camrelizumab+Pyrotinib + Chemotherapy	Oxaliplatin	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.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	[ Time Frame: Up to approximately 2 years ]	Objective response rate assessed at 18 weeks after enrollment，that is about 6 cycles of treatment

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	[ Time Frame: Up to approximately 2 years ]	The time from the beginning of treatment to the death of the patient
Progression Free Survival (PFS) per RECIST 1.1 assessed by BICR	[ Time Frame: Up to approximately 2 years ]	The time from the beginning of treatment to the progression or death of the patient

Trial Locations

Locations (1)

270 Dongan Road, Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China