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

• Sponsor: Fudan University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05111444
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 2.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Neoplasms; Gastroesophageal Junction Adenocarcinoma	Drug: Camrelizumab; Drug: Pyrotinib; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Paclitaxel; Drug: S-1	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Camrelizumab Plus Pyrotinib Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
• Anticipated Study Start Date: Dec 31, 2021
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm

Intervention/Treatment

Other: Camrelizumab+Pyrotinib + Chemotherapy 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; 200 mg on Day 1 of each 3-week cycle as an IV infusion; Drug: Pyrotinib; 320mg as continuous oral once daily on every 21 days; Drug: 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; Drug: 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; Drug: 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; Drug: 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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Overall Survival (OS) [[ Time Frame: Up to approximately 2 years ]]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	270 Dongan Road, Fudan University Shanghai Cancer Center	Shanghai		China	200032

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fudan University
• ClinicalTrials.gov Identifier: NCT05111444
• Other Study ID Numbers: OBU-SH-GC-II-010
• First Posted: Nov 8, 2021
• Last Update Posted: Nov 8, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Adenocarcinoma; Stomach Neoplasms; Paclitaxel; Capecitabine; Oxaliplatin

Study Results

No Results Posted as of Nov 8, 2021