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

NCT05111444 | Unknown Phase 2

• 1 other identifier: OBU-SH-GC-II-010
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Neoplasms; Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression Free Survival (PFS) per RECIST 1.1 assessed by BICR

  [ Time Frame: Up to approximately 2 years ]

• Overall Survival (OS)

  [ Time Frame: Up to approximately 2 years ]

Study Arms (1)

Camrelizumab+Pyrotinib + Chemotherapy

OTHER

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.

Drug: Camrelizumab; Drug: Pyrotinib; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Paclitaxel; Drug: S-1

Interventions

Camrelizumab DRUG

200 mg on Day 1 of each 3-week cycle as an IV infusion

Camrelizumab+Pyrotinib + Chemotherapy

Pyrotinib DRUG

320mg as continuous oral once daily on every 21 days

Camrelizumab+Pyrotinib + Chemotherapy

Capecitabine DRUG

1000 mg/m\^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of XELOX chemotherapy regimen

Camrelizumab+Pyrotinib + Chemotherapy

Oxaliplatin DRUG

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

Camrelizumab+Pyrotinib + Chemotherapy

Paclitaxel DRUG

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

Camrelizumab+Pyrotinib + Chemotherapy

S-1 DRUG

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

Camrelizumab+Pyrotinib + Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic HER2 positive gastric or GEJ adenocarcinoma.
• 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.
• 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.
• ECOG performance status 0-1.
• At least one measurable lesion exists as defined by RECIST 1.1 .
• Life expectancy of more than 12 weeks.

You may not qualify if:

• Hypersensitivity to Camrelizumab, pyrotinib and study chemotherapy agents and/or to any components.
• 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 \[CD137\]).
• Has an active autoimmune disease that has required systemic treatment in past 2 years.
• Has a known history of Human Immunodeficiency Virus (HIV) or active hepatitis B and C virus infection.
• Has had major surgery within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment.
• Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
• Evidence or history of coagulation disorders such as a grade ≥ 3 (CTC-AE) bleeding event.
• Known history of psychotropic substance abuse or drug use.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

270 Dongan Road, Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

camrelizumab; pyrotinib; Capecitabine; Oxaliplatin; Paclitaxel; S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Central Study Contacts

Zhe Zhang, PHD

CONTACT

8621-64175590; zhangzhe2010fduscc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: December 31, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: November 8, 2021

Record last verified: 2021-10

Locations

CN (1)