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

Gastroesophageal Junction Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05111444
• Other study ID #: OBU-SH-GC-II-010
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 31, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2021
• Source: Fudan University
• Contact: Zhe Zhang, PHD
• Phone: 8621-64175590
• Email: zhangzhe2010fduscc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Neoplasms
• Gastroesophageal Junction Adenocarcinoma
• Stomach Neoplasms

Intervention

Drug:
• Camrelizumab
200 mg on Day 1 of each 3-week cycle as an IV infusion
• Pyrotinib
320mg as continuous oral once daily on every 21 days
• Capecitabine
1000 mg/m^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of XELOX chemotherapy regimen
• Oxaliplatin
130 mg/m^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of XELOX chemotherapy regimen and as part of SOX chemotherapy regimen
• Paclitaxel
80 mg/m^2 on Day 1 and Day 8 of each 3-week cycle as an IV infusion, administered as part of FP chemotherapy regimen
• S-1
Combination product of tegafur, CDHP, and Oxo. Oral capsules BID on Days 1-14 of each 3-week cycle based on body surface area (BSA): <1.25 m^2 BSA =40 mg, 1.25 to <1.5 m^2 BSA=50 mg, =1.5 m^2 BSA=60 mg. Administered as part of SOX and TS chemotherapy regimen

Locations

Country	Name	City	State
China	270 Dongan Road, Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	Objective response rate assessed at 18 weeks after enrollment,that is about 6 cycles of treatment	[ Time Frame: Up to approximately 2 years ]
Secondary	Progression Free Survival (PFS) per RECIST 1.1 assessed by BICR	The time from the beginning of treatment to the progression or death of the patient	[ Time Frame: Up to approximately 2 years ]
Secondary	Overall Survival (OS)	The time from the beginning of treatment to the death of the patient	[ Time Frame: Up to approximately 2 years ]