New drug cocktail aims to shrink rectal tumors and avoid colostomy

NCT ID NCT07687433

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests whether adding two drugs—adebrelimab (an immunotherapy) and apatinib (a targeted therapy)—to standard chemoradiotherapy before surgery can improve outcomes for people with locally advanced or low-lying rectal cancer. The goal is to shrink the tumor enough to allow sphincter-preserving surgery, avoiding a permanent colostomy. The trial enrolls adults aged 18 to 75 with specific stages of rectal cancer who wish to preserve their anal sphincter.

What this could mean

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

Active substance
adebrelimab and apatinib combined with chemoradiotherapy
What this could lead to
If successful, this approach could allow more people with low-lying rectal cancer to avoid permanent colostomy by shrinking the tumor enough to save the anal sphincter.
What could go wrong
This is a small, early-phase trial (Phase 2) with only 43 participants. The combination may cause significant side effects, and it is not yet known if it works better than standard treatment.

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 43 people

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

Started

May 2026

Expected to finish

May 2029

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 to 75 years

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: 1. Age: 18 to 75 years, male or female; 2. Histologically or cytologically confirmed rectal cancer with measurable tumor lesion(s) (spiral CT or MRI scan ≥10 mm, meeting RECIST 1.1 criteria); 3. Clinical stage: rectal cancer cT3-4N0M0 or cT1-4N+M0, and low rectal cancer with a sphincter-preservation requirement (distance from the anal verge \<5 cm; stage T2N0M0); 4. Expected survival \>3 months; 5. ECOG PS score: 0-1; 6. No peritoneal metastasis or other distant metastasis; 7. No prior radiotherapy or immune checkpoint inhibitor therapy for rectal cancer; 8. Adequate function of vital organs as required (without the use of any blood components or cell growth factors during screening): Absolute neutrophil count ≥1.5×10⁹/L; platelet count ≥80×10⁹/L; hemoglobin ≥8.5 g/dL; Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, T3 and T4 levels should also be assessed; patients with normal T3 and T4 levels may be enrolled); Bilirubin ≤1.5×ULN; ALT and AST ≤2.5×ULN; Serum creatinine ≤1.5×ULN; 9. Women of childbearing potential must have a negative pregnancy test (β-HCG) before starting treatment. Women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception consistently during treatment and for 6 months after the last dose; 10. Subjects voluntarily participate in the study and sign the informed consent form. Exclusion Criteria: 1. Prior pelvic or abdominal radiotherapy; 2. Tumor expected to be unresectable after neoadjuvant therapy; 3. Pregnant or breastfeeding women, or women/ men of childbearing potential who refuse to use contraceptive measures; 4. History of other malignancies within the past 5 years, except for adequately treated cervical carcinoma in situ or cutaneous squamous cell carcinoma, or well-controlled basal cell carcinoma of the skin; 5. Uncontrolled symptomatic brain metastases, or poorly controlled psychiatric disorders, or severe intellectual or cognitive impairment; 6. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired pulmonary function; 7. Active, known, or suspected autoimmune disease. Subjects with stable conditions not requiring systemic immunosuppressive therapy are eligible, e.g., type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, and alopecia); 8. Congestive heart failure, uncontrolled arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack, severe hypertension refractory to medication, or other conditions rendering the patient unable to tolerate surgery; 9. Severe active infection requiring intravenous antibiotic therapy during the screening period; 10. Known allergy to the study drug or any of its excipients, or a history of severe allergic reaction to other monoclonal antibodies; 11. Clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to enrollment; 12. Hypertension that remains uncontrolled despite antihypertensive therapy prior to enrollment; 13. Patients with dysphagia; 14. Receipt of or planned receipt of live vaccines within 30 days prior to administration of adebrelimab; 15. Known history of HIV infection, or active hepatitis B or hepatitis C; 16. Inability to comply with the study protocol or to cooperate with follow-up; 17. Other conditions that the investigator considers inappropriate for participation in this trial.

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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

  • No. 150, Haping Road, Nangang District, Harbin, Heilongjiang Province, China

    Harbin, Heilongjiang, 158100, China

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