Rectal CancerPhase 2NCT07509424
Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Locally Advanced HER2-expressing Rectal Cance
A Phase 2 study testing disitamab vedotin, sintilimab, capecitabine in people with Rectal Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
After signing the informed consent form, patients who met the inclusion and exclusion criteria were given the full course of neoadjuvant treatment: short-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- disitamab vedotin, sintilimab, capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2026to 10 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in this study, are able to sign the informed consent form, and demonstrate good compliance.
- Subjects are aged between 18 and 75 years (at the time of signing the informed consent form), regardless of gender.
- Subjects are diagnosed with locally advanced rectal cancer by histology and/or cytology, with the lower edge of the tumor ≤10 cm from the anal verge. According to the 8th edition of the AJCC criteria, the disease is diagnosed as locally advanced. Based on endoscopic ultrasound or enhanced CT/MRI scans (combined with diagnostic laparoscopic exploration if necessary), the cTNM stage is T3 - 4N+, and the subjects agree to undergo total mesorectal excision.
- The tumor is ≤5 cm from the anal verge and the subject has a need for anal - preservation, or pelvic MRI shows high - risk features (meeting one of the following conditions):
- 1) CT stage cT4a or cT4b 2) Extramural vascular invasion (EMVI+) 3) Clinical lymph node (CN) stage cN2, involving the mesenteric fascia 3)Positive lateral lymph nodes 5. Subjects have not previously received systematic treatment for the current disease, including anti - tumor radiotherapy, chemotherapy, immunotherapy, etc.
- 6. IHC results confirm HER2 expression (defined as IHC 1+, 2+, 3+). 7. The ECOG score is 0 - 1. 8. The estimated survival time is ≥6 months. 9. The functions of major organs are good, meeting the following criteria: 10. In the blood routine examination (without blood transfusion and without using hematopoietic stimulating factors to correct the state within 14 days): Hemoglobin (Hb) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet (PLT) ≥80×10⁹/L.
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- 11. In the biochemical examination: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Total serum bilirubin (TBIL) ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance rate ≥60 mL/min.
- 12. In terms of coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) ≤1.5×ULN.
- 13. According to Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥50%.
- 14. The doctor clinically determines that the subject has sufficient organ function.
- 15. Subjects of child - bearing potential must use appropriate contraceptive methods during the study and within 120 days after the study ends. The serum pregnancy test should be negative within 7 days before study enrollment, and the subjects must not be lactating.
Who cannot join
- Diagnosis of a malignant disease other than colorectal cancer within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ).
- Tumor lesions with a bleeding tendency (e.g., presence of an active ulcerated tumor lesion with a positive fecal occult blood test, history of hematemesis or melena within 2 months before signing the informed consent form, judged by the investigator to be at risk of major gastrointestinal bleeding, etc.) or having received blood transfusion within 4 weeks before the study drug administration.
- Inability to take oral medications.
- Currently participating in an interventional clinical research treatment, or having received other research drugs or used research devices for treatment within 4 weeks before the first dose.
- Previous exposure to the following therapies: anti - HER2, anti - PD - 1, anti - PD - L1, anti - PD - L2 drugs, or drugs targeting another stimulatory or co - inhibitory T - cell receptor (including but not limited to CTLA - 4, OX - 40, CD137, etc.).
- Systemic treatment with Chinese patent medicines with anti - tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose.
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- Occurrence of an active autoimmune disease requiring systemic treatment (e.g., use of disease - modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment.
- Receiving systemic glucocorticoid treatment (excluding nasal spray, inhaled, or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study. Note: Use of physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) is allowed.
- Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Known allergy to the drugs used in this study.
- Peripheral neuropathy of grade 2 or higher.
- Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies).
- Subjects with active hepatitis B or hepatitis C (positive HBsAg with HBV DNA titer above the upper limit of normal; positive HCVAb with HCV RNA titer above the upper limit of normal).
- Vaccination with a live vaccine within 30 days before the first dose (Cycle 1, Day 1). Note: Receiving an injectable inactivated virus vaccine against seasonal influenza within 30 days before the first dose is allowed, but receiving a live attenuated influenza vaccine administered intranasally is not allowed.
- Pregnant or lactating women.
- Presence of any severe or uncontrollable systemic diseases, such as:
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- Significant and severely symptomatic and uncontrollable abnormalities in rhythm, conduction, or morphology on a resting electrocardiogram, such as complete left bundle - branch block, cardiac conduction block of grade II or higher, ventricular arrhythmia, or atrial fibrillation.
- Unstable angina, congestive heart failure, chronic heart failure of New York Heart Association (NYHA) class 2 or higher.
- Any arterial thrombosis, embolism, or ischemia (such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack) within 6 months before enrollment for treatment.
- Poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
- History of non - infectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose, or current presence of clinically active interstitial lung disease.
- Active pulmonary tuberculosis.
- Presence of an active or uncontrolled infection requiring systemic treatment.
- Presence of clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction.
- Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis.
- Poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L).
- Urine routine indicating urine protein ≥ ++ and confirmed 24 - hour urine protein quantification > 1.0 g.
- Patients with mental disorders who are unable to cooperate with treatment. 17. History, evidence of disease, treatment, or abnormal laboratory test values that may interfere with the test results or prevent the subject from participating in the study throughout, or other situations considered by the investigator as unsuitable for enrollment. The investigator believes that there are other potential risks that make the subject unsuitable for this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Locally Advanced HER2-expressing Rectal Cance: Preliminary Results of a Prospective, Single-arm, Phase II Study.
After signing the informed consent form, patients who met the inclusion and exclusion criteria were given the full course of neoadjuvant treatment: short-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators.
Read the detailed description
After signing the informed consent form, patients who met the inclusion and exclusion criteria were given the full course of neoadjuvant treatment: short-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators.
- Conditions
- Rectal Cancer
- Being tested
- disitamab vedotin, sintilimab, capecitabine
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disitamab vedotin, sintilimab, capecitabineDrug
short-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators.
| Study group | Role | What they receive |
|---|---|---|
| RC48 group | Experimental | short-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators. Receives: Drug: disitamab vedotin, sintilimab, capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR) rate
The primary end point was CR rate, which was calculated by dividing the number of patients with a pCR for those who underwent surgery and a cCR for those who underwent WW by the total number of evaluable patients. The pCR was defined as the absence of any tumor cells from the primary tumor and lymph nodes in the specimen after radical surgery (ypT0N0) or the absence of any tumor cells in the lesion after local resection (ypT0). The cCR was defined as the absence of residual disease on DRE, MRI, and endoscopy.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start22 Apr 2026 (estimated)
- Primary completion10 Apr 2029 (estimated)
- Study completion10 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509424
- Sponsor's protocol ID
- 002502
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Locally Advanced HER2-expressing Rectal Cance: Preliminary Results of a Prospective, Single-arm, Phase II Study.
- ClinicalTrials.gov ID
- NCT07509424
- Acronym / sponsor ID
- 002502
- Conditions
- Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 22 Apr 2026 (estimated)
- Primary completion
- 10 Apr 2029 (estimated)
- Study completion
- 10 Jul 2029 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After signing the informed consent form, patients who met the inclusion and exclusion criteria were given the full course of neoadjuvant treatment: short-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators.
Detailed description
After signing the informed consent form, patients who met the inclusion and exclusion criteria were given the full course of neoadjuvant treatment: short-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RC48 group | Experimental | Drug: disitamab vedotin, sintilimab, capecitabineshort-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects voluntarily participate in this study, are able to sign the informed consent form, and demonstrate good compliance.
- Subjects are aged between 18 and 75 years (at the time of signing the informed consent form), regardless of gender.
- Subjects are diagnosed with locally advanced rectal cancer by histology and/or cytology, with the lower edge of the tumor ≤10 cm from the anal verge. According to the 8th edition of the AJCC criteria, the disease is diagnosed as locally advanced. Based on endoscopic ultrasound or enhanced CT/MRI scans (combined with diagnostic laparoscopic exploration if necessary), the cTNM stage is T3 - 4N+, and the subjects agree to undergo total mesorectal excision.
- The tumor is ≤5 cm from the anal verge and the subject has a need for anal - preservation, or pelvic MRI shows high - risk features (meeting one of the following conditions):
- 1) CT stage cT4a or cT4b 2) Extramural vascular invasion (EMVI+) 3) Clinical lymph node (CN) stage cN2, involving the mesenteric fascia 3)Positive lateral lymph nodes 5. Subjects have not previously received systematic treatment for the current disease, including anti - tumor radiotherapy, chemotherapy, immunotherapy, etc.
Key exclusion criteria (29 listed)
- Diagnosis of a malignant disease other than colorectal cancer within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ).
- Tumor lesions with a bleeding tendency (e.g., presence of an active ulcerated tumor lesion with a positive fecal occult blood test, history of hematemesis or melena within 2 months before signing the informed consent form, judged by the investigator to be at risk of major gastrointestinal bleeding, etc.) or having received blood transfusion within 4 weeks before the study drug administration.
- Inability to take oral medications.
- Currently participating in an interventional clinical research treatment, or having received other research drugs or used research devices for treatment within 4 weeks before the first dose.
- Previous exposure to the following therapies: anti - HER2, anti - PD - 1, anti - PD - L1, anti - PD - L2 drugs, or drugs targeting another stimulatory or co - inhibitory T - cell receptor (including but not limited to CTLA - 4, OX - 40, CD137, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| disitamab vedotin, sintilimab, capecitabineshort-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators. | Drug | RC48 group |
Primary outcome
Complete response (CR) rate
Time frame: Perioperative
The primary end point was CR rate, which was calculated by dividing the number of patients with a pCR for those who underwent surgery and a cCR for those who underwent WW by the total number of evaluable patients. The pCR was defined as the absence of any tumor cells from the primary tumor and lymph nodes in the specimen after radical surgery (ypT0N0) or the absence of any tumor cells in the lesion after local resection (ypT0). The cCR was defined as the absence of residual disease on DRE, MRI, and endoscopy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing disitamab vedotin, sintilimab, capecitabine in people with Rectal Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 11 inclusion and 29 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: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zhenyu Lin (15827130893, whxhlzy@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (CR) rate (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.