c-CetuIRI Versus Ersecond-line Irinotecan s-IRI-CetuIRI

NCT04833036 | Unknown Phase 2 DMC

• 1 other identifier: Cetu-IRI
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The primary endpoint is to evaluate the progression-free survival (PFS).

Conditions

Colorectal Cancer

Keywords

chemotherapy

Outcome Measures

Primary Outcomes (1)

• PFS

  progression free survival

  up to 8 weeks

Secondary Outcomes (2)

• OS

  through study completion, an average of half year

• ORR

  up to 8 weeks

Study Arms (2)

c-CetuIRI

ACTIVE COMPARATOR

Irinotecan combined with cetuximab

Drug: Irinotecan; Drug: cetuximab

s-IRI-CetuIRI

EXPERIMENTAL

single irinotecan first, then irinotecan plus cetuximab sequentially after PD

Drug: Irinotecan; Drug: cetuximab

Interventions

Irinotecan DRUG

180 mg/m2, ivgtt d1，q2w

c-CetuIRI; s-IRI-CetuIRI

cetuximab DRUG

500 mg/m2, ivgtt d1，q2w

c-CetuIRI; s-IRI-CetuIRI

Eligibility Criteria

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

You may qualify if:

• Signing informed consent;
• Age is greater than or equal to 18 years old;
• Metastatic colorectal adenocarcinoma confirmed by tissue or cytopathology;
• First-line failure to use oxaliplatin combined with fluorouracil (with or without anti-angiogenic targeting drugs);
• One or more measurable lesions, the longest diameter of the spiral CT scan is at least 10 mm, and the diameter of the conventional CT scan is at least 20 mm (the solid tumor efficacy evaluation standard, RECIST standard, version 1.1);
• The Eastern Cancer Cooperative Group (ECOG) has a general status score of 0-2;
• The bone marrow capacity, liver and kidney function reached the following criteria within 7 days before screening:
• Absolute neutrophil count ≥ 1.5x109 / L; hemoglobin ≥ 9.0 g / dl; platelet count ≥ 80 x 109 / L; total bilirubin ≤ 1.5 times normal upper limit (ULN); alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN Alkaline phosphatase ≤ 3 x ULN; serum creatinine ≤ 1.5 x ULN;
• Women of childbearing age need to take effective contraception.
• RAS, B-RAF gene wild type

You may not qualify if:

• Previous use of irinotecan or anti-egfr therapy for advanced colorectal cancer (e.g. Cetuximab, panizumab, etc.);
• History of HIV infection or active chronic hepatitis b or c (high copy viral DNA);
• Patients with important organ failure or other important diseases: patients with serious heart disease including congestive heart failure, uncontrolled arrhythmia, angina requiring long-term medication, heart valve disease, myocardial infarction, pericardial effusion with obvious symptoms, and refractory hypertension;A history of severe neurological or psychiatric problems;Severe infection;Active disseminated intravascular coagulation
• Active severe clinical infection;
• Symptomatic brain or meningeal metastasis (unless the patient was treated for \> for 6 months, had negative imaging results within 4 weeks prior to study entry, and had stable tumour-related clinical symptoms at study entry);
• Patients whose seizures require treatment (e.g. steroids or antiepileptic therapy);
• Receiving renal dialysis;
• Have a history of other malignant tumors within 5 years, except for cured cervical carcinoma in situ or skin basal cell carcinoma, except for those whose metastasis can be confirmed by pathology to be from other tumor sources;
• Chronic intestinal diseases, infectious intestinal diseases and intestinal obstruction;
• Drug abuse and medical, psychological or social conditions may interfere with patients' participation in studies or affect the assessment of their findings;
• Any unstable condition or condition that may endanger the safety and compliance of patients;
• Pregnant or lactating women;Having fertility but not taking adequate contraceptive measures;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; Cetuximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Weijian Guo, Professor

CONTACT

86-21-64175590; mingzhuhuang0718@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 12, 2019
• First Posted: April 6, 2021
• Study Start: October 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: November 1, 2022
• Last Updated: April 6, 2021

Record last verified: 2021-04

Locations

CN (1)