First-line Maintenance of OH2 Injection for Advanced Colorectal Cancer (NCT05648006) | Clinical Trial Compass
TerminatedPhase 2
First-line Maintenance of OH2 Injection for Advanced Colorectal Cancer
Stopped: Strategy adjustment
China7 participantsStarted 2023-10-17
Plain-language 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.
Who can participate
Age range17 Years – 75 Years
SexALL
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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;
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;