Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer

NCT05193292 | Unknown Phase 2

• 1 other identifier: FUSCC-CamreTrastumCRC
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the efficacy and safety of camrelizumab combined with trastuzumab and chemotherapy in Patients with HER2-positive advanced colorectal cancer

Conditions

Colorectal Neoplasms; Intestinal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The proportion of patients with complete response or partial response according to RECIST v1.1

  [ Time Frame: Approximately 24 months ]

Secondary Outcomes (4)

• Progression-Free Survival

  [ Time Frame: Approximately 24 months ]

• Disease Control Rate

  [ Time Frame: Approximately 24 months ]

• Overall Survival

  [ Time Frame: Approximately 24 months ]

• Duration of Response

  [ Time Frame: Approximately 24 months ]

Study Arms (1)

Camrelizumab combined with trastuzumab and chemotherapy

EXPERIMENTAL

Camrelizumab: 200mg, iv, 21d for a treatment cycle Trastuzumab: 8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle Chemotherapy will either be XELOX, mFOLFOX6, FOLFIRI, mXELIRI or mIRIS

Drug: Camrelizumab; Drug: Trastuzumab; Drug: XELOX regimen; Drug: mFOLFOX6 regimen; Drug: FOLFIRI regimen; Drug: mXELIRI regimen; Drug: mIRIS regimen

Interventions

Camrelizumab DRUG

200mg, iv, 21d for a treatment cycle

Camrelizumab combined with trastuzumab and chemotherapy

Trastuzumab DRUG

8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle

Camrelizumab combined with trastuzumab and chemotherapy

XELOX regimen DRUG

Oxaliplatin, 130 mg/m2, iv, d1; Capecitabine, 1000 mg/m2, po, bid, d1-d14; q3w

Camrelizumab combined with trastuzumab and chemotherapy

mFOLFOX6 regimen DRUG

Oxaliplatin, 85 mg/m2, iv, d1; Leucovorin, 400 mg/m2, iv, d1; 5-FU, 400mg/m2, iv, d1 followed by 1200 mg/(m2·d)\*2d, civ, 46h; q2w

Camrelizumab combined with trastuzumab and chemotherapy

FOLFIRI regimen DRUG

Irinotecan, 180 mg/m2, iv, d1; Leucovorin, 400 mg/m2, iv, d1; 5-FU, 400mg/m2, iv, d1 followed by 1200 mg/(m2·d)\*2d, civ, 46h; q2w

Camrelizumab combined with trastuzumab and chemotherapy

mXELIRI regimen DRUG

Irinotecan, 200 mg/m2, iv, d1; capecitabine, 800 mg/m2, po, bid, d1-d14; q3w

Camrelizumab combined with trastuzumab and chemotherapy

mIRIS regimen DRUG

Irinotecan, 180 mg/m2, iv, d1; Tiggio Capsules (S-1), 40-60 mg/m2, po, bid, d1-d9; q2w

Camrelizumab combined with trastuzumab and chemotherapy

Eligibility Criteria

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

You may qualify if:

• Subjects has voluntarily agreed to sign the informed consent and have good compliance and are willing to cooperate with follow-up.
• Age 18 years or older, male or female.
• Have a life expectancy of at least 3 months.
• Histologically confirmed diagnosis of unresectable recurrent or metastatic HER2 positive colorectal cancer.
• HER2 positivity defined as the colorectal cancer-specific HERACLES diagnostic criteria or NGS sequencing of tumor tissue/blood samples showed HER2 amplification.
• Patients have not received systemic anti-cancer treatment in the past or had disease progression more than 6 months after receiving after (neo)adjuvant treatment could be enrolled or failure of first-line therapy or completion of (new) adjuvant therapy to disease recurrence less than 6 months.
• At least one measurable or evaluable lesion, as defined by RECIST 1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• The functional level of the major organs must meet the following requirements:(1)Blood routine: neutrophils (ANC) ≥1.5×10\^9/L; platelet count (PLT)≥90×10\^9/L; hemoglobin (Hb) ≥90 g/L; (2)Blood biochemistry: TBIL≤1.5×ULN; ALT and AST≤2.5×ULN; Cr≤1.5×ULN and creatinine clearance≥50 mL/min (Cockcroft-Gault formula); for subjects with liver metastasis: TBIL≤3×ULN; ALT and AST≤5×ULN; (3)Patients was not receiving anticoagulation therapy (INR ≤ 1.5 or aPTT ≤ 1.5 × ULN). If the patient received prophylactic anticoagulation therapy and the INR ≤ 2 × ULN within 14 days before the start of the study and the aPTT/PPT is within the normal range could be enrolled; (4)Left ventricular ejection fraction (LVEF) ≥55% (within 28 days).
• Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period.

You may not qualify if:

• Have previously received any co-stimulatory or co-inhibitory T cell receptor antibody or drug therapy, including PD-1, PD-L1, PD-L2, CD137, CTLA-4, etc.
• Have previously received anti-HER2 targeted therapy (monoclonal antibody or small molecule TKI).
• Have any active autoimmune diseases or autoimmune diseases in the past 2 years.
• Have used immunosuppressive drugs within 4 weeks before the first dose of study drug treatment.
• Allergic to any monoclonal antibody or chemotherapeutic drug preparation component.
• Receive a live attenuated vaccine within 4 weeks before the first dose of study drug treatment.
• Known symptomatic central nervous system metastases and/or cancerous meningitis. If subjects with brain metastases who have been treated in the past are in stable condition, they could be enrolled.
• Pleural and abdominal effusion requiring clinical treatment, or third interspace effusion.
• Suffering from congenital or acquired immune deficiency.
• Known history of human immunodeficiency virus (HIV) infection.
• Subjects who have received allogeneic tissue/solid organ transplantation.
• Known to have active tuberculosis.
• Known to have acute or chronic active hepatitis B or acute or chronic active hepatitis C.
• Severe infections that are active or poorly clinical controlled.
• Known history of (non-infectious) pneumonia requiring steroid treatment or currently suffering from pneumonia.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

270 Dongan Road, Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Intestinal Neoplasms

Interventions

camrelizumab; Trastuzumab; XELOX

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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: December 12, 2021
• First Posted: January 14, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: January 14, 2022

Record last verified: 2021-12

Locations

CN (1)