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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi)

Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi) (NCT06229041) is a Phase 3 interventional studying Rectal Cancer, sponsored by Peking University Cancer Hospital & Institute. 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

The goal of this clinical trial is to compare the PCR rate between Total Neoadjuvant Treatment ±Immunotherapy in high risk locally advanced rectal cancer. The main questions it aims to answer are: * The PCR rate between the two groups * The 3years DFS between the two groups * Chemoradiotherapy and immunotherapy toxicity * Postoperative complications Participants will receive total neoadjuvant treatment ±immunotherapy followed by surgery. Researchers will compare neoadjuvant treatment ±immunotherapy to see the PCR rate.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Rectal Cancer, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory 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.

A target enrollment of 472 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. \>18,\<75 years old 2. ECOG score 0-1 3. colorectal adenocarcinoma confirmed by pathology 4. The distance between the lower margin of the tumor and the anal margin is ≤12cm or the distance between the anorectal ring (ARJ) is ≤8cm 5. The initial local MRI stage was T4b, or mrN2, or positive MRF, or positive EMVI, or lateral lymph node metastasis (mrLLND+) 6. No evidence of distant metastasis 7. No history of pelvic radiotherapy 8. No history of rectal cancer surgery or chemotherapy 9. Systemic infections that do not require antibiotic treatment 10. Not associated with immune system diseases 11. Blood routine: ANC\>1.5 cells/mm3, HGB\>9.0g /dL, PLT\>800,000/mm3 12. Blood biochemistry: total bilirubin ≤1.5xULN, AST≤2.5xULN, ALT≤2.5xULN; 13. Serum creatinine ≤1.5 times the upper limit of normal and endogenous kidney function (creatinine clearance) at least 50mL/min (Cockcroft-Gault formula) 14. Patients with well-controlled hypertension were allowed to be enrolled 15. International Standardized ratio (INR), activated partial thromboplastin time (aPTT) ≤1.5 times the upper limit of normal value (only applicable to patients who have not received anticoagulant therapy; Patients receiving anticoagulant therapy should keep anticoagulants within the therapeutic requirements) 16. Normal or abnormal FT3, FT4 and TSH have no clinical significance 17. Normal cardiac function, that is, normal or abnormal ECG examination has no clinical significance, and left ventricular ejection fraction (LVEF) shown by cardiac ultrasound is greater than 50% 18. The patient read and signed the willing to sign a consent form of this study and agreed to participate in this study 19. The subjects voluntarily joined the study, signed the willing to sign a consent form, had good compliance and cooperated with the follow-up. It is recommended that all patients provide tumor tissue samples (preferably fresh) for pathological/genetic testing prior to enrollment ...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. \>18,\<75 years old 2. ECOG score 0-1 3. colorectal adenocarcinoma confirmed by pathology 4. The distance between the lower margin of the tumor and the anal margin is ≤12cm or the distance between the anorectal ring (ARJ) is ≤8cm 5. The initial local MRI stage was T4b, or mrN2, or positive MRF, or positive EMVI, or lateral lymph node metastasis (mrLLND+) 6. No evidence of distant metastasis 7. No history of pelvic radiotherapy 8. No history of rectal cancer surgery or chemotherapy 9. Systemic infections that do not require antibiotic treatment 10. Not associated with immune system diseases 11. Blood routine: ANC\>1.5 cells/mm3, HGB\>9.0g /dL, PLT\>800,000/mm3 12. Blood biochemistry: total bilirubin ≤1.5xULN, AST≤2.5xULN, ALT≤2.5xULN; 13. Serum creatinine ≤1.5 times the upper limit of normal and endogenous creatinine clearance ≥50mL/min (Cockcroft-Gault formula) 14. Patients with well-controlled hypertension were allowed to be enrolled 15. International Standardized ratio (INR), activated partial thromboplastin time (aPTT) ≤1.5 times the upper limit of normal value (only applicable to patients who have not received anticoagulant therapy; Patients receiving anticoagulant therapy should keep anticoagulants within the therapeutic requirements) 16. Normal or abnormal FT3, FT4 and TSH have no clinical significance 17. Normal cardiac function, that is, normal or abnormal ECG examination has no clinical significance, and left ventricular ejection fraction (LVEF) shown by cardiac ultrasound is greater than 50% 18. The patient read and signed the informed consent of this study and agreed to participate in this study 19. The subjects voluntarily joined the study, signed the informed consent, had good compliance and cooperated with the follow-up. It is recommended that all patients provide tumor tissue samples (preferably fresh) for pathological/genetic testing prior to enrollment 20. Fertile men or women with the possibility of becoming pregnant must use a highly effective contraceptive method throughout the trial and continue contraception for 12 months after the end of treatment Exclusion Criteria: 1. Recurrent rectal cancer 2. Microsatellite instability (MSI) or mismatch repair gene deletion (dMMR) 3. The patient has had other malignancies in the past 5 years (in addition to properly treated basal cell carcinoma and skin squamous cell carcinoma) 4. The patient has had arterial embolic diseases in the past 6 months, such as angina pectoris, MI, TIA, CVA, etc. 5. Have received other types of anti-tumor or experimental therapy 6. The patient is a pregnant or lactating woman 7. The patient has other diseases or mental disorders that may affect the patient's participation in this study 8. Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy or VEGFR TKI therapy. 9. Major surgical procedures were performed/received within 4 weeks prior to the first administration of the study drug or the side effects of which have not yet recovered, live vaccination, immunotherapy, and radiotherapy within 2 weeks. 10. Study patients who had received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week before the first administration of the drug. 11. Known allergy to the investigational drug and its components 12. Active lung disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or a history of active tuberculosis. 13. Have any clinical problems beyond your control, including but not limited to: a persistent or active (severe) infection b Poorly controlled hypertension (persistent blood pressure greater than 150/90 MMHG) c Poorly controlled diabetes mellitus d Heart disease (Grade III/IV congestive heart failure or heart block as defined by the Heart Society of New York) e Have or suspect an autoimmune disease, or a history of autoimmune disease or syndromes requiring treatment with a steroid/immunosuppressive system, such as hypophysitis, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.; 14. Other severe, acute, or chronic medical conditions or abnormalities in laboratory tests that the investigator determines may increase the risk associated with study participation or may interfere with the interpretation of the study results.

Treatments Being Tested

DRUG

Camrelizumab +Immunotherapy

Camrelizumab was used in preoperative treatment.

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.

Beijing Cancer Hospital
Beijing, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06229041), the sponsor (Peking University Cancer Hospital & Institute), 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 NCT06229041 clinical trial studying?

The goal of this clinical trial is to compare the PCR rate between Total Neoadjuvant Treatment ±Immunotherapy in high risk locally advanced rectal cancer. The main questions it aims to answer are: * The PCR rate between the two groups * The 3years DFS between the two groups * Chemoradiotherapy and immunotherapy toxicity * Postoperative complications Participants will receive total neoadjuvant treatment ±immunotherapy followed by surgery. Researchers will compare neoadjuvant treatment ±immunotherapy to see the PCR rate. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06229041?

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 NCT06229041?

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 NCT06229041. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06229041. 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 2026-06-26 · Data from ClinicalTrials.gov.