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Squamous Cell Cancer of the Oral CavityEarly Phase 1NCT04278989

Inhibition of Oral Tumorigenesis by Antitumor B

A Early Phase 1 study testing Anti-tumor B in people with Squamous Cell Cancer of the Oral Cavity, run by Medical College of Wisconsin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a window of opportunity study of Anti-tumor B (ATB). Anti-tumor B is a botanical agent composed of six Chinese herbs: Sophora tonkinensis, Polygonum bistorta, Prunella vulgaris, Sonchus brachyotus, Dictamnus dasycarpus, and Dioscorea bulbifera. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Cancer of the Oral Cavity
What is being tested?
Anti-tumor B
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
22 Apr 2022to 5 Jun 2025
Phase
Early Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • In the event that the diagnosis of squamous cell cancer is made by an outside pathologist, hence not verified, the patient can start study agent administration but histological confirmation of squamous cell cancer (SCC) of the oral cavity (or histologic variants of SCC) by the pathologist must happen within seven days of registration in order to continue protocol therapy. Note: patients whose confirmatory biopsy fails to demonstrate invasive carcinoma will be excluded from continued participation in the study and considered a screen failure.
  • Clinical stage II-IVA (as defined by the American Joint Committee on Cancer (AJCC), 8th Edition), and amenable to surgical resection.
  • New diagnosis of oral SCC, new second primary, or recurrent oral SCC following a minimum remission of six months following previous definite surgery.
  • History and physical examination by an otolaryngologist and medical oncologist within 14 calendar days of study registration.
  • Zubrod/ECOG Performance status < 2.
Show all 35Show fewer
  • Age ≥ 18 years.
  • Complete Blood Count (CBC)/differential obtained within 14 calendar days prior to registration, with adequate bone marrow function defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3;
  • Platelets ≥ 100,000 cells/mm^3;
  • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable).
  • Adequate renal and hepatic function within 14 calendar days prior to registration, defined as follows:
  • Serum creatinine < 1.5 mg/dl or creatinine clearance (CCr) ≥ 50 ml/min within 14 calendar days prior to registration, determined by 24-hour collection or estimated by Cockcroft-Gault formula:
  • CCr male = [(140 - age) x (wt in kg)]
  • [(Serum Cr mg/dl) x (72)]
  • CCr female = 0.85 x (CrCl male)
  • Total bilirubin < 2 x the institutional upper limit of normal (ULN);
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x the institutional ULN;
  • Magnesium, calcium, glucose, potassium, and sodium within 14 calendar days prior to registration, with the following required parameters:
  • Magnesium: > 0.9 mg/dl or < 3 mg/dl;
  • Calcium: > 7 mg/dl or < 12.5 mg/dl;
  • Glucose: > 40 mg/dl or < 250 mg/dl;
  • Potassium: > 3 mmol/L or < 6 mmol/L;
  • Sodium: > 130 mmol/L or < 155 mmol/L.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Female subjects must meet one of the following:
  • Postmenopausal for at least one year before enrollment, OR
  • Surgically sterile (i.e., undergone a hysterectomy or bilateral oophorectomy), OR
  • If subject is of childbearing potential (defined as not satisfying either of the above two criteria), agrees to practice two acceptable methods of contraception (combination methods require use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom, hormonal contraceptive) from the time of signing of the informed consent form through 21days after the last dose of study agent, OR
  • Agrees to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable contraception methods.)
  • Male subjects, even if surgically sterilized (i.e., status postvasectomy), must agree to one of the following:
  • Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR
  • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)
  • Enrollment on an interventional postoperative study is allowed if study agents do not overlap.
  • Gastric tube drug administration is permissible.

Who cannot join

  • Pregnant or lactating women are ineligible due to unforeseeable risks to embryo or fetus.
  • Concurrent use of any medicinal botanical, natural, or other herbal compounds.
  • Planned subtotal or debulking surgery is not permissible.
  • Prior systemic chemotherapy for oral SCC; note that prior chemotherapy for a different cancer is allowable.
  • Prior radiotherapy for oral SCC is permissible if disease free for one year since prior oral cancer treatment and free of significant late radiation effects.
  • Severe active comorbidity, such as uncontrolled cardiac disease, infection, and severe chronic obstructive pulmonary disease (COPD).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

This is a window of opportunity study of Anti-tumor B (ATB). Anti-tumor B is a botanical agent composed of six Chinese herbs: Sophora tonkinensis, Polygonum bistorta, Prunella vulgaris, Sonchus brachyotus, Dictamnus dasycarpus, and Dioscorea bulbifera.

Read the detailed description

This study began as a randomized study and was amended to an open label, single arm study.

Upon initiating study treatment, patients will start taking the study drug. The duration of treatment will depend upon scheduling of their surgery--typically from the time surgery is scheduled it will be seven to 28 days. Four (300 mg) pills will be taken three times per day until the evening prior to surgery.

The primary endpoint is to determine the antiproliferative effects of ATB as determined by tumor Ki-67 in baseline tumor biopsy compared to resected control tumor tissue from untreated subjects. The control group is a mixture of contemporaneous placebo patients plus matched control patients.

Being tested
Anti-tumor B

What participants receive

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

  • Anti-tumor BDrug

    Also called Zeng-Sheng-Ping, ACAPHA, ATB

    1,200 mg, three times a day for seven to 28 days (dependent on scheduled surgery).

Study groups in NCT04278989
Study groupRoleWhat they receive
Anti-tumor BExperimental1,200 mg three times a day.
Receives: Drug: Anti-tumor B

What is being measured

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

  1. Percent of Ki-67 Positive Cells

    This measure is the immunohistochemical evaluation using the antihuman Ki-67 monoclonal antibody MIB-1 and reporting the percentage of positively stained malignant cells.

    Measured: Baseline and after surgery (seven to 28 days after baseline)

Timeline

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

  1. First posted20 Feb 2020
  2. Study start22 Apr 2022
  3. Primary completion19 May 2025
  4. Study completion5 Jun 2025

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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04278989
Sponsor's protocol ID
PRO00037907
Status last verified
Mar 2026
First submitted
19 Feb 2020
Last updated
25 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Anti-tumor B in people with Squamous Cell Cancer of the Oral Cavity, run by Medical College of Wisconsin at 1 site in United States.

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 35 inclusion and 6 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: finished, as of the sponsor's last update on 25 Mar 2026. 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 United States. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent of Ki-67 Positive Cells (time frame: Baseline and after surgery (seven to 28 days after baseline)). 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 NCT04278989.

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 25 Mar 2026.

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