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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study

Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study (UNION PRECISION-I)

Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study (NCT06234007) is a Phase 2 interventional studying Locally Advanced Rectal Cancer, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To investigate the efficacy and safety of short-course radiotherapy sequential fruquintinib in combination with adebrelimab and CAPOX (full course neoadjuvant therapy) in patients with locally advanced rectal cancer.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Locally Advanced Rectal Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 45 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Signed written willing to sign a consent form and volunteered to participate in the study; 2. Age 18-75 years old (including the cut-off value), male or female; 3. Locally advanced rectal adenocarcinoma confirmed by histopathology; 4. High risk on pelvic MRI \[one of the following criteria\] : - Clinical tumor (cT) stage cT4a or cT4b (according to the AJCC, 8th edition) - Extramural vascular infiltration - Clinical lymph node (cN) stage cN2 (according to the AJCC, 8th edition) - Involvement of the mesenteric fascia - Enlarged lateral lymph nodes 5. The distance between the lower edge of the tumor and the anal edge is ≤10cm; 6. Able to swallow tablets and capsules normally; 7. ECOG PS 0-1 8. Have not received any anti-tumor treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. 9. Plan to undergo surgery after completion of total neoadjuvant therapy; 10. No surgical contraindications; 11. Normal major organ function, including: 1. Routine blood test (no blood transfusion and blood products within 14 days prior to the first treatment, no correction with G-CSF and other hematopoietic stimulating factors) : - Neutrophil count ≥ 1.5×109/L - Platelet count ≥ 100×109/L - blood count (hemoglobin) at least 90 g/L - White blood cell count ≥ 3.0×109/L 2. Blood biochemical tests: - Total bilirubin ≤ 1.5×ULN (Gilbert's syndrome subjects, ≤3×ULN; Tumor liver metastasis, total bilirubin ≤3×ULN) - ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN (≤5×ULN for patients with liver metastases) - Serum creatinine ≤ 1.5×ULN, or kidney function (creatinine clearance) at least 50 mL/min (Cocheroft-Gault formula, see Annex 2) 3. Coagulation function: - International Normalized ratio (INR) ≤ 1.5×ULN - Activated partial thromboplastin time (APTT) ≤ 1.5×ULN - Prothrombin time (PT) ≤1.5×ULN 4. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥50% ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Signed written informed consent and volunteered to participate in the study; 2. Age 18-75 years old (including the cut-off value), male or female; 3. Locally advanced rectal adenocarcinoma confirmed by histopathology; 4. High risk on pelvic MRI \[one of the following criteria\] : * Clinical tumor (cT) stage cT4a or cT4b (according to the AJCC, 8th edition) * Extramural vascular infiltration * Clinical lymph node (cN) stage cN2 (according to the AJCC, 8th edition) * Involvement of the mesenteric fascia * Enlarged lateral lymph nodes 5. The distance between the lower edge of the tumor and the anal edge is ≤10cm; 6. Able to swallow tablets and capsules normally; 7. ECOG PS 0-1 8. Have not received any anti-tumor treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. 9. Plan to undergo surgery after completion of total neoadjuvant therapy; 10. No surgical contraindications; 11. Normal major organ function, including: 1. Routine blood test (no blood transfusion and blood products within 14 days prior to the first treatment, no correction with G-CSF and other hematopoietic stimulating factors) : * Neutrophil count ≥ 1.5×109/L * Platelet count ≥ 100×109/L * Hemoglobin ≥ 90 g/L * White blood cell count ≥ 3.0×109/L 2. Blood biochemical tests: * Total bilirubin ≤ 1.5×ULN (Gilbert's syndrome subjects, ≤3×ULN; Tumor liver metastasis, total bilirubin ≤3×ULN) * ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN (≤5×ULN for patients with liver metastases) * Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min (Cocheroft-Gault formula, see Annex 2) 3. Coagulation function: * International Normalized ratio (INR) ≤ 1.5×ULN * Activated partial thromboplastin time (APTT) ≤ 1.5×ULN * Prothrombin time (PT) ≤1.5×ULN 4. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥50% 12. Female subjects of childbearing potential were required to have a negative serum pregnancy test within 14 days before starting the trial drug and to have used an effective contraceptive method (e.g., an intrauterine device, contraceptive pill, or condom) during the trial and for at least 6 months after the last dose; Male participants whose partner is a woman of childbearing potential should use effective contraception during the trial and for 6 months after the last dose; Exclusion Criteria: 1. Previous allergic history to any anti-angiogenesis targeted drug, any component of monoclonal antibody, capecitabine, oxaliplatin, or other platinum drugs; 2. Have received or are receiving any of the following: * being treated with an immunosuppressive drug, or systemic hormone, for immunosuppression within 2 weeks before the first dose of the study drug (dose\&gt; 10mg/ day prednisone or equivalent); Inhaled or topical steroid use and dosage are allowed in the absence of active autoimmune disease; Prednisone 10mg/ day or equivalent dose of adrenocortical hormone replacement; * received live attenuated vaccine within 4 weeks before the first dose of study drug; * major surgery or severe trauma within 4 weeks before the first dose of study drug; 3. Have any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered after hormone replacement therapy); Patients with psoriasis or complete remission of childhood asthma/allergies without any intervention in adulthood were considered for inclusion, but patients requiring medical intervention with bronchodilators were not included. 4. A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation or allogeneic bone marrow transplantation; 5. The presence of uncontrolled cardiac symptoms or diseases, including but not limited to: (1) heart failure above NYHA class II, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias without or poorly controlled after clinical intervention; (5) patients with hypertension that is not well controlled with a single antihypertensive drug (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100mmHg), or patients using two or more antihypertensive drugs to control blood pressure; (6) New York Heart Association (NYHA) functional class \&gt; Grade II or left ventricular ejection fraction (LVEF) \< 50%; 6. Severe infection (CTCAE \> 2) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; Prophylactic antibiotics were excluded if there was active pulmonary inflammation on baseline chest imaging, if there were signs and symptoms of infection within 14 days before the first dose of study drug, or if oral or intravenous antibiotics were required; 7. Patients with active pulmonary tuberculosis infection detected by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year before enrollment but without regular treatment; 8. Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive, and HCV RNA above the detection limit of the analytical method); 9. The patient had a second primary malignancy; 10. Pregnant or lactating women; 11. History of arterial/venous thrombosis events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 12. Persons with a history of psychotropic drug abuse and inability to quit or with mental disorders; 13. Patients with any constitutional sign or history of bleeding regardless of severity; 14. Patients with high risk of bleeding, such as active bleeding or bleeding tendency; 15. Urine routine test showed urine protein ≥++, and confirmed 24-hour urine protein quantitation \> 1.0 g; 16. According to the investigator's judgment, there are other factors that may lead to the forced termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, alcohol abuse, drug abuse, family or social factors, and factors that may affect the safety or compliance of the subjects.

Treatments Being Tested

DRUG

Fruquintinib, Adebrelimab, Oxaliplatin, Capecitabine

Safety run-in phase: Fruquintinib 4mg/d, oral, once daily, continuous treatment for 2 weeks, 1 week off, q3w, 6 cycles; If the number of patients experiencing dose-limiting toxicity (DLT) was ≤1, the study would continue at that dose level. If the number of patients with DLTs was \>1, the dose of fruquintinib was decreased to 3mg/d, qd po, d1-14, q3w, and the dose expansion phase was continued;Adebrelimab 1200mg, d1, IV infusion, q3W, 6 cycles; Capecitabine 1000 mg/m2, twice a day, po, d1-14, followed by 7 days of rest, q3W, 6 cycles; Oxaliplatin 130 mg/m2, d1, q3W, 6 cycles; Dose expansion phase: Fruquintinib RP2D, qd po, d1-14, q3w, 6 cycles; Adebrelimab 1200mg, d1, IV infusion, q3W, 6 cycles; Capecitabine 1000 mg/m2, twice a day, po, d1-14, followed by 7 days of rest, q3W, 6 cycles; Oxaliplatin 130 mg/m2, d1, q3W, 6 cycles;

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06234007), the sponsor (Union Hospital, Tongji Medical College, Huazhong University of Science and Technology), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06234007 clinical trial studying?

To investigate the efficacy and safety of short-course radiotherapy sequential fruquintinib in combination with adebrelimab and CAPOX (full course neoadjuvant therapy) in patients with locally advanced rectal cancer. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06234007?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06234007?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06234007. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06234007. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.