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New drug combo aims to wipe out rectal tumors before surgery

NCT ID NCT02688712

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding the experimental drug galunisertib to standard chemoradiation can improve outcomes for people with locally advanced rectal cancer. About 50 participants will receive the combination over 8 weeks, followed by surgery. Researchers will also study tumor and blood samples to understand who responds and how the immune system reacts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Galunisertib (LY2157299)
What this could lead to
If successful, this could lead to a more effective treatment for locally advanced rectal cancer, potentially improving the chance of a complete tumor response before surgery.
What could go wrong
This is a small, early-phase trial (50 people) and the drug is experimental. It may not work better than standard treatment, and side effects from combining it with chemoradiation are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2016

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients (male and female) with histologically confirmed rectal adenocarcinoma, AJCC Stage IIA-IIIC or AJCC Stage IV appropriate for consideration of primary rectal tumor resection. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Age 18 years or above. * Laboratory values (performed within 28 days prior to enrollment) as follows: * WBC ≥3.0 109/L * Hgb ≥9g/dl (patients may be transfused to reach this level) * Platelets ≥99 109 /L * Creatinine ≤1.5X upper limit of laboratory normal * AST/ALT ≤5 X upper limit of laboratory normal * Total bilirubin ≤1.5X upper limit of laboratory normal * BNP ≤ 3 times the baseline value and upper limit of laboratory normal * Troponin I ≤ upper limit of laboratory normal * hsCRP ≤ upper limit of laboratory normal * Cystatin ≤ upper limit of laboratory normal * PT/INR ≤1.5X upper limit of laboratory normal * Pre-menopausal women must have a negative pregnancy test on the day treatment starts and must avoid becoming pregnant while on treatment and for 3 months following completion of therapy. Men must avoid fathering a child while on treatment and for 3 months following completion of therapy. This exclusion is required due to the toxicities that chemotherapy, radiation, and LY2157299 may have on the forming fetus, spermatogenesis or the nursing child. Also, because pregnancy may alter immune function it may limit the treatment efficacy. Women of childbearing potential must agree to use a medically approved contraceptive method during the treatment period and for 3 months following the last dose of LY2157299. Contraceptive methods may include an intrauterine device \[IUD\], birth control pills or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. * No active bleeding. * Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy. Exclusion Criteria: * Active infection requiring systemic antibiotics. * Active autoimmune disease as defined by the autoimmune disease assessment tool (see protocol) * Diagnosis of a solid tumor malignancy (excluding non-melanoma skin cancer) within 3 years of enrollment. * History of prior pelvic radiation. * Aortic aneurysm (see protocol) * Abnormal Echocardiogram (see protocol) * Immunodeficiency, need for immunosuppressive medications, or need for chronic steroids. * Participation in any investigational drug study within 28 days of enrollment. * Pregnant or lactating women, as treatment involves risks to the embryo or fetus. * Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol. * History of cardiac disease, including myocardial infarction within 6 months before study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension, major cardiac abnormalities, a predisposition for developing aneurysms including family history of aneurysms, Marfan syndrome, bicuspid aortic valve, or evidence of damage to the large vessels of the heart. * Concomitant use of strong CYP3A4 inhibitors and inducers

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Providence Cancer Center

    Portland, Oregon, 97213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.