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Locally Advanced Rectal Cancer (LARC)Phase 2NCT07581626

Short-Course Online Adaptive Radiotherapy Combined With Chemotherapy, Targeted Therapy and Immunotherapy as Total Neoadjuvant Therapy (TNT) for Locally Advanced Rectal Cancer

A Phase 2 study testing SCRT+targeted therapy+immunotherapy+chemotherapy in people with Locally Advanced Rectal Cancer (LARC), run by Chinese PLA General Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Standard treatment for patients with proficient mismatch repair (pMMR) / microsatellite stable (MSS) locally advanced rectal cancer (LARC) consists primarily of neoadjuvant chemoradiotherapy followed by radical surgery. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Locally Advanced Rectal Cancer (LARC)
What is being tested?
SCRT+targeted therapy+immunotherapy+chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 May 2026to 1 Apr 2028
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

  • Voluntarily signed the informed consent form.
  • Aged 18-75 years (inclusive of 18 and 75 years).
  • pMMR/MSS.
  • Middle or low rectal cancer located ≤10 cm from the anal verge as assessed by MRI.
  • Histopathologically confirmed locally advanced rectal adenocarcinoma and high-risk features confirmed by pelvic MRI (meeting any of the following criteria: clinical stage cT3N+ or cT4N0/+; MRF+ or EMVI+; enlarged lateral pelvic lymph nodes).
  • ECOG PS of 0-1.
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  • Expected survival ≥2 years.
  • No prior anti-tumor therapy.
  • At least one measurable lesion with a longest diameter ≥10 mm measured by MRI (by RECIST version 1.1).
  • Organ functions meeting the following requirements (no blood products or cell growth factors allowed within 14 days prior to enrollment):
  • Absolute neutrophil count ≥1.5×10⁹/L; Platelet count ≥100×10⁹/L; Hemoglobin ≥90 g/L; Total bilirubin <1.5×ULN; ALT and/or AST <2.5×ULN; Serum creatinine <1.5×ULN; Creatinine clearance ≥50 mL/min.
  • Women of childbearing potential must use effective contraceptive measures.
  • Good compliance and willingness to comply with follow-up requirements.

Who cannot join

  • Unable to comply with the study protocol or study procedures.
  • Patients with contraindications to surgery.
  • Patients with metastatic disease or recurrent rectal cancer.
  • Uncontrolled active autoimmune disease or active inflammatory disease at enrollment, or receiving immunosuppressive therapy.
  • History of organ transplantation.
  • Known interstitial lung disease (ILD) or unexplained persistent cough and dyspnea.
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  • Patients with familial adenomatous polyposis (FAP), hereditary non-polyposis colorectal cancer (HNPCC), active Crohn's disease, or active ulcerative colitis.
  • Other malignancy diagnosed within 5 years prior to enrollment, except for radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
  • Severe cardiovascular disease within 6 months prior to enrollment, including unstable angina pectoris or myocardial infarction.
  • Subjects with hypersensitivity to the investigational product or any of its excipients.
  • Participation in another clinical trial of an unapproved/investigational drug within 4 weeks prior to enrollment and having received the corresponding investigational product.
  • Clinically significant electrolyte abnormalities judged by the investigator.
  • Uncontrolled hypertension prior to enrollment, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg despite medication.
  • Poorly controlled diabetes mellitus prior to enrollment (fasting glucose concentration ≥ CTCAE Grade 2 after standard treatment).
  • Any disease or condition affecting drug absorption prior to enrollment, or inability of the patient to take oral medication.
  • Active gastrointestinal diseases such as gastric and duodenal ulcer, ulcerative colitis prior to enrollment, or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation.
  • Severe active bleeding within 3 months prior to enrollment, hemoptysis (>5 mL fresh blood within 4 weeks), or thromboembolic event (including stroke and/or transient ischemic attack) within 12 months.
  • Clinically significant cardiovascular disease including but not limited to: acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure with New York Heart Association (NYHA) classification > Grade 2; ventricular arrhythmia requiring pharmacotherapy; left ventricular ejection fraction (LVEF) < 50%.
  • Active or uncontrolled severe infection (≥ CTCAE v5.0 Grade 2).
  • Known human immunodeficiency virus (HIV) infection. Known clinically significant liver disease history, including viral hepatitis:
  • Hepatitis B virus (HBV) carriers with active HBV infection (HBV DNA positive: >1×10⁴ copies/mL or >2000 IU/mL);
  • Known hepatitis C virus (HCV) infection with positive HCV RNA (>1×10³ copies/mL).
  • Unresolved toxicities higher than CTCAE v5.0 Grade 1 resulting from any prior anti-cancer therapy, excluding alopecia, lymphopenia, and oxaliplatin-induced neurotoxicity ≤ Grade 2.
  • Female subjects who are pregnant (positive pregnancy test before treatment) or breastfeeding.
  • Urinalysis showing urine protein ≥ 2+ and 24-hour urinary protein > 1.0 g.
  • Any other disease, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the investigator's judgment, renders the patient unsuitable for the study drug (e.g., seizure disorder requiring treatment), interferes with the interpretation of study results, or places the patient at high risk.
  • Patients considered unsuitable for inclusion in this study by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Guanghai Dai, MD contact

+86 13801232381

463043539@qq.com

China1 site

  • China PLAGH

    Beijing

Other trials in China

About this study

Official title: A Single-Arm, Phase 2 Clinical Study on the Efficacy and Safety of Short-Course Online Adaptive Radiotherapy Combined With Chemotherapy, Targeted Therapy and Immunotherapy as Total Neoadjuvant Therapy (TNT) for Locally Advanced Rectal Cancer

Standard treatment for patients with proficient mismatch repair (pMMR) / microsatellite stable (MSS) locally advanced rectal cancer (LARC) consists primarily of neoadjuvant chemoradiotherapy followed by radical surgery. Several studies (including the UNION, STELLAR, TORCH, and SPRING-01 trials, etc) have demonstrated that the neoadjuvant strategy of short-course radiotherapy followed by chemotherapy combined with immunotherapy can improve pCR rate in patients with pMMR/MSS LARC, and might also provide higher organ preservation rates and long-term survival benefits. The study aims to explore the efficacy and safety of a TNT regimen comprising short-course radiotherapy combined with chemotherapy, cetuximab N01 (for patients with wild-type RAS/BRAF) or bevacizumab (for patients with mutant RAS/BRAF), and sintilimab in patients with high-risk LARC.

Being tested
SCRT+targeted therapy+immunotherapy+chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCRT+targeted therapy+immunotherapy+chemotherapyDrug

    SCRT: 25 Gy, 5 Gy × 5 fr.

    One week after completion of SCRT:

    1. Patients with wild-type RAS/BRAF: mFOLFOX6: oxaliplatin 85 mg/m², leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² IV bolus on Day 1; followed by 5-fluorouracil 2400 mg/m² continuous infusion over 46 hours, q2w; sintilimab 200 mg/m² IV infusion on Day 1, q3w; cetuximab N01 500 mg/m² IV infusion on Day 1, q2w; Combination therapy for 18 weeks (9 cycles of chemotherapy).
    2. Patients with mutant RAS/BRAF:

    CAPOX: oxaliplatin 130 mg/m² IV ivgtt, D1; capecitabine 1000 mg/m² BID, po, D1-14, q3w, for 6 cycles; sintilimab 200 mg/m² ivgtt, D1, q3w, for 6 cycles; bevacizumab 7.5 mg/kg IV infusion on Day 1, q3w, for 5 cycles

Study groups in NCT07581626
Study groupRoleWhat they receive
SCRT+Sintilimab+Cetuximab N01/Bevacizumab+mFOLFOX6/CAPOXExperimentalNot described
Receives: Drug: SCRT+targeted therapy+immunotherapy+chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response (CR)

    CR = Pathological Complete Response (pCR) + Clinical Complete Response (cCR)

    Measured: Within 3 months after surgery

Secondary outcomes (8)

  1. R0 resection rate

    Proportion of patients achieving a margin-negative tumor removal

    Measured: Within 3 months after surgery

  2. LER

    Local Excision rate

    Measured: Within 3 months after surgery

  3. ORR

    Objective Response Rate of neoadjuvant therapy ( by RECIST 1.1)

    Measured: Around 6 months after recruitment

  4. DCR

    Disease Control Rate of neoadjuvant therapy (by RECIST 1.1)

    Measured: Around 6 months after recruitment

  5. 3y-EFS

    3 years events-free survival

    Measured: Around 3 years after recruitment

  6. 3y-RFS

    3 years recurrence-free Survival

    Measured: Around 3 years after recruitment

  7. OS

    Overall Survival

    Measured: Around 5 years after recruitment

  8. Safety Measures

    Incidence and grades of treatment related adverse events (by NCI-CTCAE 5.0) and surgery related safeties

    Measured: Within 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2028 (estimated)

Resources

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07581626
Sponsor's protocol ID
KL-A140-02
Status last verified
May 2026
First submitted
21 Apr 2026
Last updated
18 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCRT+targeted therapy+immunotherapy+chemotherapy in people with Locally Advanced Rectal Cancer (LARC), run by Chinese PLA General Hospital at 1 site in China.

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 13 inclusion and 27 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Guanghai Dai, MD (+86 13801232381, 463043539@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response (CR) (time frame: Within 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07581626.

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 18 May 2026.

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