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Advanced Colorectal CarcinomaPhase 2NCT05648006

First-line Maintenance of OH2 Injection for Advanced Colorectal Cancer

A Phase 2 study testing OH2, Capecitabine and Bevacizumab in people with Advanced Colorectal Carcinoma, run by Binhui Biopharmaceutical Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 17 to 75 years
Conditions the study is for
Advanced Colorectal Carcinoma
What is being tested?
OH2, Capecitabine and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteChina
Study dates
17 Oct 2023to 15 Apr 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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;
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  • 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) :
  • WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥100×109/L, Hb≥90 g/L;
  • Serum creatinine ≤1.5×ULN;
  • TBIL≤1.5×ULN;
  • ALT and AST≤2.5×ULN; Patients with liver metastasis ≤5×ULN;
  • Normal coagulation: International normalized ratio INR≤1.5×ULN or prothrombin time (PT, APTT) ≤1.5×ULN;
  • For patients with herpes, it takes 3 months after the herpes subsides;
  • I have fully understood the research and voluntarily signed the informed consent, and I expect good compliance;
  • For women of childbearing age, the blood pregnancy test must be negative within 7 days before the first medication;
  • The use of at least one medically approved contraceptive method (e.g. surgical sterilization, oral contraceptives, intrauterine devices, controlled sexual desire or barrier contraception combined with spermicide) by fertile women and men with a partner of a woman of reproductive age for at least six months from the signing of the informed consent form until the last trial drug treatment.

Who cannot join

  • 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);
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  • 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;
  • Patients who developed other malignant tumors within 5 years prior to inclusion, except for cervical carcinoma in situ, low-risk gastrointestinal stromal tumor, in situ or early stage breast cancer, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and papillary carcinoma of the thyroid, which were effectively resected and required no further antitumor therapy and had a recurrence survival rate of more than 70% in 5 years;
  • Patients with active autoimmune disease or a history of autoimmune disease that may recur, but patients with the following diseases are not excluded and can be further screened:
  • Type 1 diabetes
  • Hypothyroidism (if controlled with hormone replacement therapy alone)
  • Controlled celiac disease
  • Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, hair loss)
  • Patients for any condition requiring systemic therapy with glucocorticoids (prednisone >10 mg/ day or equivalent dose of the same drug) or other immunosuppressant within 14 days prior to the administration of the investigational drug, but who are currently or previously on any of the following steroid regimens may be enrolled:
  • Epinephrine substitute steroid (prednisone ≤10 mg/ day or equivalent dose of similar drugs)
  • Systemic absorption of minimal amounts of local, ocular, intra-articular, intranasal or inhaled corticosteroids
  • Prophylactic short-term (≤7 days) use of corticosteroids (e.g., allergy to contrast media) or to treat non-autoimmune conditions (e.g., delayed hypersensitivity caused by contact allergens)
  • Patients with grade 2 or above radiation pneumonia during previous antitumor therapy, or pulmonary diseases such as pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and severe impairment of lung function;
  • Pleural effusion or ascites with clinical symptoms requiring repeated drainage (≥1 time/month);
  • Other researchers did not consider it appropriate to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: 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

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.

Being tested
OH2, Capecitabine, Bevacizumab
Keywords
Oncolytic Virus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OH2Biological

    Oncolytic Type 2 Herpes Simplex Virus

  • CapecitabineDrug

    1000 mg/m2, orally administered twice a day, D1 to D14, repeated every 3 weeks

  • BevacizumabDrug

    Bevacizumab: 7.5 mg/kg, intravenously, once every 3 weeks.

Study groups in NCT05648006
Study groupRoleWhat they receive
OH2+CapecitabineExperimentalOH2: 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
Receives: Biological: OH2; Drug: Capecitabine
Capecitabine/Capecitabine+BevacizumabActive comparatorCapecitabine: 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.
Receives: Drug: Capecitabine; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Time after treatment to clinical and radiographic disease progression will be evaluated.

    Measured: 2 years

Secondary outcomes (7)

  1. Durable response rate (DRR)

    objective response lasting continuously 6 months

    Measured: 2 years

  2. Overall survival (OS)

    The overall survival for each patient receiving treatment will be calculated.

    Measured: 2 years

  3. Objective response rate (ORR)

    Determination of the ORR will be calculated based on the proportion of patients achieving CR or PR using the RECIST v1.1 and iRECIST as assessed by investigators.

    Measured: 2 years

  4. Disease control rate (DCR)

    DCR will be calculated based on the proportion of patients achieving CR, PR, or who have SD at least 6 weeks after receiving first dose of study treatment.

    Measured: 2 years

  5. Duration of response (DoR)

    DOR will be calculated from the time of initial response (CR or PR) documentation to the time of progressive disease (PD). If a subject who had CR or PR dies without the evidence of disease progression, the case will be censored at the time point of death when analyzing DOR

    Measured: 2 years

  6. Immune-progression-free survival (iPFS)

    Time after treatment to disease progression using the iRECIST will be evaluated.

    Measured: 2 years

  7. Toxicity by CTCAE v5.0

    Safety assessments should be conducted for all subjects who received treatment at least once. Adverse events will be graded according to CTCAE v5.0.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2022
  2. Study start17 Oct 2023
  3. Primary completion15 Apr 2024
  4. Study completion15 Apr 2024

Why it stopped: Strategy adjustment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05648006
Sponsor's protocol ID
BH-OH2-010
Status last verified
Apr 2024
First submitted
5 Dec 2022
Last updated
30 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OH2, Capecitabine and Bevacizumab in people with Advanced Colorectal Carcinoma, run by Binhui Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategy adjustment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05648006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.

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