New drug cocktail aims to shrink rectal tumors and avoid colostomy
NCT ID NCT07687433
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Rectal cancer patients are added.
By submitting, you agree to our Terms of use
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Blood test and CT combo may spare rectal cancer patients a second surgery
- Radiation may spare early rectal cancer patients from radical surgery
- Vaccinia virus targets rectal tumors in new immunotherapy combo
- New triple therapy aims to wipe out rectal cancer before surgery
- Robot vs. transanal surgery: which is better for low rectal cancer?
- New drug combo could boost rectal cancer remission before surgery