A Prospective, Multicenter, Open, Randomized Controlled Phase II Clinical Study Evaluating Recombinant Oncolytic HSV2（OH2）Therapeutic Injecta(Vero Cell) for Human Use(rHSV2hGM-CSF) in Combination With Capecitabine for First-line Maintenance Therapy in Advanced Colorectal Cancer

Binhui Biopharmaceutical Co., Ltd.1 site in 1 country7 target enrollmentOctober 17, 2023

ConditionsAdvanced Colorectal Carcinoma

InterventionsOH2 Capecitabine Bevacizumab

Overview

Phase: Phase 2
Intervention: OH2
Conditions: Advanced Colorectal Carcinoma
Sponsor: Binhui Biopharmaceutical Co., Ltd.
Enrollment: 7
Locations: 1
Primary Endpoint: Progression-free survival
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, multicenter, open, randomized controlled Phase II clinical study to evaluate the efficacy and safety of intratumoral injection of OH2 combined with capecitabine for first-line maintenance of advanced colorectal cancer.

Registry

clinicaltrials.gov

Start Date

October 17, 2023

End Date

April 15, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Binhui Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 to 75 years old (including boundary values), male or female;
•Patients with advanced colorectal adenocarcinoma (Stage IV) with a definite histological or cytological diagnosis;
•Partial response (PR) or stable disease (SD) was evaluated in advanced colorectal cancer patients after 16 to 24 weeks of first-line treatment with fluorouracil-based chemotherapy combined with or without targeted drugs, and before the last chemotherapy to trial drug administration;
•The physical status score of the Eastern Oncology Consortium (ECOG) was 0\~1;
•Have at least one measurable or evaluable lesion according to RECIST 1.1;
•There are lesions suitable for intratumoral injection;
•At least 2 weeks and no more than 4 weeks after the end of the last first-line chemotherapy;
•Expected survival ≥12 weeks;
•Patients with asymptomatic BMS after treatment who are free of disease progression by computed tomography (CT) or magnetic resonance imaging (MRI), stable for at least 12 weeks and without steroid medication for at least 4 weeks;
•Laboratory examination (no blood transfusion or use of blood products, no correction therapy with granulocyte colony stimulating factor or other hematopoietic stimulating factor within 14 days prior to the first dose) :

Exclusion Criteria

•Patients who plan to undergo radical excision of metastatic lesions；
•Unrelieved intestinal obstruction or malabsorption syndrome;
•Adverse reactions caused by first-line chemotherapy drugs did not recover to ≤ grade 1 before randomization (except hair loss and peripheral neurotoxicity less than or equal to grade 2);
•Cardiovascular disease meets one of the following criteria: Congestive heart failure with ≥NYHA Level III heart function; Severe arrhythmias requiring medical treatment; Acute myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, or stenting within 6 months prior to initial administration; Left ventricular ejection fraction (LVEF) \<50%; Adjusted QTc interval (Fridericia formula correction) \>450 ms for men and \>470 ms for women, or risk factors for tip twisting ventricular tachycardia such as clinically significant hypokalemia as determined by the investigator, a family history of long QT syndrome, or a family history of arrhythmia (such as pre-excited syndrome); High blood pressure that is not effectively controlled;
•Patients had active infection or unexplained fever \>38.5℃ during screening or before initial administration;
•Patients with congenital or acquired immune deficiency (such as HIV infection), syphilis antibody positive and syphilis rapid plasma reactin-positive, active hepatitis (hepatitis B: HBsAg positive and HBV DNA≥2000 IU/mL; Hepatitis C: HCV antibody positive and HCV virus copy number \> upper limit of normal);
•Had received or was receiving or still required to receive other experimental agents or antiviral therapy within 4 weeks before randomization (hepatitis B patients were treated with entecavir, tenofovir fumarate dipifurofurl, adefovir dipivoxil sustainably);
•Participated in other clinical studies within 4 weeks prior to randomization;
•Known to be allergic to the test drug or its active ingredients or excipients, or severely allergic;
•A known history of psychotropic substance abuse, alcohol or drug abuse;

Arms & Interventions

OH2+Capecitabine

OH2: 10\^7 CCID50/mL intratumoral injection, once every 2 weeks; Capecitabine: 1000 mg/m2, orally administered twice a day, D1 to D14, repeated every 3 weeks

Intervention: OH2

OH2+Capecitabine

OH2: 10\^7 CCID50/mL intratumoral injection, once every 2 weeks; Capecitabine: 1000 mg/m2, orally administered twice a day, D1 to D14, repeated every 3 weeks

Intervention: Capecitabine

Capecitabine/Capecitabine+Bevacizumab

Capecitabine: 1000 mg/m2, orally administered twice a day, D1 to D14, repeated every 3 weeks Bevacizumab: 7.5 mg/kg, intravenously, once every 3 weeks.

Intervention: Capecitabine

Capecitabine/Capecitabine+Bevacizumab

Capecitabine: 1000 mg/m2, orally administered twice a day, D1 to D14, repeated every 3 weeks Bevacizumab: 7.5 mg/kg, intravenously, once every 3 weeks.

Intervention: Bevacizumab