AzTrials
AzTrials

Rectal CancerPhase 2mRCAT-ENCT07068763

Node-Sparing Short-Course Radiation Combined With Capecitabine and PD-1/CTLA-4 for MSS Early Rectal Cancer

A Phase 2 study testing Lymph-node-sparing short-course radiotherapy, Capecitabine and PD-1/CTLA-4 inhibitor (Aiparolitoworixureli injection) in people with Rectal Cancer, run by Sir Run Run Shaw Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a single-arm, prospective, multicenter study evaluating a novel neoadjuvant treatment strategy for patients with early, mid-low rectal adenocarcinoma that is microsatellite stable (MSS). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rectal Cancer
What is being tested?
Lymph-node-sparing short-course radiotherapy, Capecitabine and PD-1/CTLA-4 inhibitor (Aiparolitoworixureli injection)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
9 Oct 2025to 31 Dec 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.
  • Male or Female aged 18-80.
  • Patients diagnosed with low rectal cancer within 7 cm from the lower edge of the tumor to the anal verge by pelvic MRI and rectal ultrasound, the clinical stage is cT2-3N0M0.
  • Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.
  • Eastern Cooperative Oncology Group (ECOG) score 0-1.
  • No previous treatment (including anti-tumor therapy, immunotherapy or pelvic radiation).
  • Informed consent form signed.

Who cannot join

  • Patients with a previous history of malignant tumors besides rectal cancer.
  • Patients with distant metastases before enrollment.
  • Patients with metastatic regional or non-regional lymph nodes are assessed by MRI or CT.
  • Patients with obstruction, perforation, or bleeding that require emergency surgery.
  • Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
  • Allergic to any component of the therapy.
Show all 13Show fewer
  • Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy.
  • Contraindications to radiotherapy and chemotherapy.
  • Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening.
  • Factors leading to study termination, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) requiring combination therapy, and patients with severe laboratory abnormalities. Patients with congenital or acquired immune deficiency (such as HIV infection).
  • Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc.
  • Other conditions that investigators consider not suitable for this study.
  • Patient not suitable for participating by other concerns of researchers.

Trial locations and contacts

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

Bingjun Bai, MD contact

8613858816897

echobai@zju.edu.cn

China1 site, 1 recruiting

  • Sir run run shaw hospital

    Hangzhou, Zhejiang

    Bingjun Bai, 8613858816897, echobai@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Node-Sparing Short-Course Radiation Combined With Capecitabine and PD-1/CTLA-4 for MSS Early Middle and Low Rectal Cancer (mRCAT-E): An Open-label, Single-arm, Prospective Multicenter Clinical Trial

This is a single-arm, prospective, multicenter study evaluating a novel neoadjuvant treatment strategy for patients with early, mid-low rectal adenocarcinoma that is microsatellite stable (MSS). Instead of irradiating regional lymph nodes, we deliver short-course radiotherapy (25 Gy in 5 fractions) exclusively to the primary tumor ("lymph-node-sparing" approach), immediately followed by four 3-week cycles of capecitabine plus combined PD-1/CTLA-4 immune checkpoint inhibitors. Two weeks after completing chemo-immunotherapy, tumor response is assessed. Patients who achieve a clinical complete response may enter a "watch-and-wait" program; others will undergo local excision or total mesorectal excision (TME) as appropriate. The primary endpoint is the rate of complete response (clinical and pathological). Secondary endpoints include organ-preservation rate, 3-year local recurrence, 3-year disease-free and overall survival, toxicity, and quality-of-life measures. Results from a pilot study suggest that this regimen may substantially improve complete response rates while reducing radiation-related toxicity, potentially allowing more patients to avoid radical surgery and permanent stoma.

Conditions
Rectal Cancer
Being tested
Lymph-node-sparing short-course radiotherapy, Capecitabine, PD-1/CTLA-4 inhibitor (Aiparolitoworixureli injection)
Keywords
lymph-node-sparing short-course radiotherapy, capecitabine, PD-1 inhibitor, CTLA-4 inhibitor, organ preservation, clinical complete response
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • Lymph-node-sparing short-course radiotherapyRadiation

    Three-dimensional conformal or intensity-modulated radiotherapy targeting only the primary tumor bed (no regional lymph nodes), delivering a total dose of 25 Gy in 5 Gy fractions over five consecutive days.

  • CapecitabineDrug

    Oral capecitabine 1,000 mg/m² administered twice daily on Days 1-14 of each 21-day cycle, for a total of four cycles.

  • PD-1/CTLA-4 inhibitor (Aiparolitoworixureli injection)Drug

    Intravenous PD-1/CTLA-4 bispecific monoclonal antibody at 5 mg/kg every 3 weeks for four cycles, starting on Day 8 after completion of radiotherapy.

Study groups in NCT07068763
Study groupRoleWhat they receive
Experimental ArmExperimentalPatients receive lymph-node-sparing short-course radiotherapy of 25 Gy delivered in five daily fractions to the primary tumor bed (no nodal fields). Beginning on treatment Day 8, patients receive capecitabine 1,000 mg/m² orally twice daily on Days 1-14 plus PD-1/CTLA-4 inhibitor (5 mg/kg IV every 3 weeks) for four cycles. Tumor response is assessed 1-2 weeks after the last cycle; patients with clinical complete response enter a watch-and-wait program, while non-responders proceed to local excision or total mesorectal excision.
Receives: Radiation: Lymph-node-sparing short-course radiotherapy; Drug: Capecitabine; Drug: PD-1/CTLA-4 inhibitor (Aiparolitoworixureli injection)

What is being measured

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

  1. Clinical and pathological complete response rate (CR rate)

    Proportion of enrolled patients who achieve a clinical complete response (cCR) on imaging, endoscopy, and biopsy and/or a pathological complete response (pCR) in surgical specimens (if resected) following lymph-node-sparing short-course radiotherapy combined with capecitabine and PD-1/CTLA-4 inhibitor.

    Measured: Up to 12 weeks after completion of chemo-immunotherapy

Secondary outcomes (4)

  1. Organ preservation rate

    Proportion of patients who avoid total mesorectal excision (TME) and permanent stoma by remaining in watch-and-wait or undergoing only local excision.

    Measured: 1 year after enrollment

  2. 3-year local recurrence rate

    Proportion with tumor recurrence in the pelvis

    Measured: 3 years

  3. Overall survival(OS）

    The three-year overall survival of patients.

    Measured: 3 years after chemotherapy or surgery

  4. Adverse effects rate

    Rate of radiotherapy, chemotherapy and immunotherapy related adverse events

    Measured: From date of initiation of treatment until the date of death from any cause, assessed up to 3 years

Timeline

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

  1. First posted16 Jul 2025
  2. Study start9 Oct 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2029 (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
Model description
Single-arm, open-label trial
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07068763
Sponsor's protocol ID
SRRS-mRCAT-E
Acronym
mRCAT-E
Status last verified
Jan 2026
First submitted
7 Jul 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lezoche E, Guerrieri M, Paganini AM, D'Ambrosio G, Baldarelli M, Lezoche G, Feliciotti F, De Sanctis A. Transanal endoscopic versus total mesorectal laparoscopic resections of T2-N0 low rectal cancers after neoadjuvant treatment: a prospective randomized trial with a 3-years minimum follow-up period. Surg Endosc. 2005 Jun;19(6):751-6. doi: 10.1007/s00464-004-8930-x. Epub 2005 May 4.

    PubMed 15868260

  • Annals of Oncology (2024) 24 (suppl_1): 1-20. 10.1016/iotech/iotech100744

  • Habr-Gama A, Perez RO, Wynn G, Marks J, Kessler H, Gama-Rodrigues J. Complete clinical response after neoadjuvant chemoradiation therapy for distal rectal cancer: characterization of clinical and endoscopic findings for standardization. Dis Colon Rectum. 2010 Dec;53(12):1692-8. doi: 10.1007/DCR.0b013e3181f42b89.

    PubMed 21178866

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lymph-node-sparing short-course radiotherapy, Capecitabine and PD-1/CTLA-4 inhibitor (Aiparolitoworixureli injection) in people with Rectal Cancer, run by Sir Run Run Shaw 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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 6 Jan 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 Bingjun Bai, MD (8613858816897, echobai@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical and pathological complete response rate (CR rate) (time frame: Up to 12 weeks after completion of chemo-immunotherapy). 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 NCT07068763, which also lists 3 linked publications.

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 6 Jan 2026.

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