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

Primary Purpose

Gastric Neoplasms, Gastroesophageal Junction Adenocarcinoma

Status

Not yet recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Camrelizumab

Pyrotinib

Capecitabine

Oxaliplatin

Paclitaxel

S-1

About this trial

This is an interventional treatment trial for Gastric Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

270 Dongan Road, Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Camrelizumab+Pyrotinib + Chemotherapy

Arm 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.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

Objective response rate assessed at 18 weeks after enrollment，that is about 6 cycles of treatment

Secondary Outcome Measures

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

Overall Survival (OS)

The time from the beginning of treatment to the death of the patient

Full Information

NCT ID

NCT05111444

First Posted

October 27, 2021

Last Updated

October 27, 2021

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT05111444

Brief Title

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

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 31, 2021 (Anticipated)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Neoplasms, Gastroesophageal Junction Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Camrelizumab+Pyrotinib + Chemotherapy

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Camrelizumab

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Pyrotinib

Intervention Description

320mg as continuous oral once daily on every 21 days

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

S-1

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Objective response rate assessed at 18 weeks after enrollment，that is about 6 cycles of treatment

Time Frame

[ Time Frame: Up to approximately 2 years ]

Secondary Outcome Measure Information:

Title

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

Description

The time from the beginning of treatment to the progression or death of the patient

Time Frame

[ Time Frame: Up to approximately 2 years ]

Title

Overall Survival (OS)

Description

The time from the beginning of treatment to the death of the patient

Time Frame

[ Time Frame: Up to approximately 2 years ]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhe Zhang, PHD

Phone

8621-64175590

zhangzhe2010fduscc@gmail.com

Facility Information:

Facility Name

270 Dongan Road, Fudan University Shanghai Cancer Center

City

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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