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AzTrials

Low Rectal CancerPhase 2mRCATNCT05972655

Nodes-sparing Short-course Radiation Combined With CAPOX and Tislelizumab for MSS Middle and Low Rectal Cancer

A Phase 2 study testing Modified short-course radiotherapy, PD-1 antibody and Capecitabine in people with Low 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 an open-label, prospective, multicenter phase II clinical trial to evaluate modified short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) for patients with MSS middle and low rectal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Low Rectal Cancer
What is being tested?
Modified short-course radiotherapy, PD-1 antibody and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
2 Aug 2023to 1 May 2026
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

  • Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.
  • Male or Female aged 18-75.
  • Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT2N+M0/cT3-4aN0/+M0, the lymph nodes are limited to the mesorectum, the circumferential resection margin is negative.
  • 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) 0-1.
  • No previous treatment(including anti-tumor therapy、immunotherapy or pelvic radiation).
  • Adequate hematologic, hepatic, renal, thyroid and cardiac function: white blood cells ≥3500/mm3, neutrophils ≥1800/mm3, platelets ≥100,000/mm3, hemoglobin ≥100 g/L; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.25 × ULN, serum albumin ≥28 g/L. creatinine clearance ≥50 mL/mi, creatinine ≤1.5 × ULN;
  • 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 positive internal or external iliac 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 with poorly differentiated adenocarcinoma, signet ring cell carcinoma, or mucinous adenocarcinoma.
  • Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy.
  • 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.

Trial locations and contacts

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

Zhangfa Song, M.D, PH.D contact

+86 13867421652

songzhangfa@zju.edu.cn

Cheng Cai, master contact

+86 18395995912

ColoSurg_cc@zju.edu.cn

China1 site, 1 recruiting

  • Sir Run Run Shao hospital

    Hanzhou, Zhejiang, 310012

    Zhangfa Song, Dr, +86 13867421652, songzhangfa@zju.edu.cn

    Zhangfa Song, doctor

    Recruiting

Other trials in China

About this study

Official title: Modified Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Locally Advanced of Middle and Low Rectal Cancer (mRCAT): An Open-label, Single-arm, Prospective Multicenter Clinical Trial

This is an open-label, prospective, multicenter phase II clinical trial to evaluate modified short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) for patients with MSS middle and low rectal cancer. A total of 32 patients will be enrolled in this trial. The primary endpoint is the rate of pathological complete response (pCR). The organ preservation rate, tumor regression grade, long-term prognosis, and adverse effects will also be analyzed.

Being tested
Modified short-course radiotherapy, PD-1 antibody, Capecitabine, Oxaliplatin

What participants receive

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

  • Modified short-course radiotherapyRadiation

    radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes: 25Gy/5Fx

  • PD-1 antibodyDrug

    PD-1 antibody (Tislelizumab): 200mg d1 q3w

  • CapecitabineDrug

    Capecitabine: 1000mg/m2 d1-14 q3w

  • OxaliplatinDrug

    Oxaliplatin: 130mg/m2 d1 q3w

Study groups in NCT05972655
Study groupRoleWhat they receive
Treatment ArmExperimentalParticipants will receive 5*5Gy modified short-course radiation (radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) concurrently with CAPOX and tislelizumab regimens: Oxaliplatin, 130mg/m2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg/m2, PO, BID, d1-14 and tislelizumab, 200mg intravenous infusion d1 of each cycle. CAPOX and tislelizumab repeat every 3 weeks for 4 cycles, followed by total mesorectal excision surgery.
Receives: Radiation: Modified short-course radiotherapy; Drug: PD-1 antibody; Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

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

  1. Pathological complete response (pCR) rate

    The status of pCR will be evaluated after the TME surgery.

    Measured: within 10 days after surgery

Secondary outcomes (8)

  1. Tumor regression grade

    TRG is evaluated according to the AJCC system. TRG0-1 is defined as good response, TRG2 as moderate response, and TRG3 as poor response.

    Measured: within 10 days after surgery

  2. Local recurrence rate(LRR)

    Presence of adenocarcinoma within the rectal wall or within the mesorectum confirmed by pathology.

    Measured: 3 years after sugery

  3. Disease free survival(DFS)

    The three-year disease-free survival of patients.

    Measured: 3 years after surgery

  4. Overall survival(OS)

    The three-year overall survival of patients.

    Measured: 3 years after surgery

  5. 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 5 years

  6. Rectal specific quality of life assessment via QLQ-CR29

    Rectal specific quality of life according to European Organization for Research and Treatment of Cancer ( EORTC) Quality of life questionnaire QLQ-CR29. scale from 0 to 100, A higher scale represents better function and a higher quality of life.

    Measured: Baseline and months 3, 6, 12, 24, 36, 60 after the surgery

  7. Quality of life assessment via QLQ-C30

    Quality of life according to EORTC Quality of life Questionnaire QLQ-C30 version 3.0. Score range from 0 to 100 points. A higher score represents better function and a higher quality of life.

    Measured: Baseline and months 3, 6, 12, 24, 36, 60 after the surgery

  8. Validation of the Wexner score

    The change of severity of fecal incontinence assessment according to Wexner score. a score from 0-20, where 0 is perfect continence and 20 is complete incontinence.

    Measured: Months 3, 6, 12, 24, 36, 60 after the surgery

Timeline

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

  1. First posted2 Aug 2023
  2. Study start2 Aug 2023
  3. Primary completion20 Aug 2024
  4. Study completion1 May 2026 (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
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05972655
Sponsor's protocol ID
SRRS-mRCAT
Acronym
mRCAT
Status last verified
Jan 2025
First submitted
20 Jul 2023
Last updated
9 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cai C, Zhang X, Sun X, Wang H, Chen E, Chen L, Gu B, Wang J, Huang X, Lao W, Wang X, Chen M, Ding S, Du J, Song Z. Node-sparing modified short-course Radiotherapy Combined with CAPOX and Tislelizumab for locally Advanced MSS of Middle and low rectal Cancer (mRCAT): an open-label, single-arm, prospective, multicentre clinical trial. BMC Cancer. 2024 Oct 9;24(1):1247. doi: 10.1186/s12885-024-12994-0.

    PubMed 39385104

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Modified short-course radiotherapy, PD-1 antibody and Capecitabine in people with Low 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 8 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 9 Jan 2025. 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 Zhangfa Song, M.D, PH.D (+86 13867421652, songzhangfa@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rate (time frame: within 10 days 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 NCT05972655, which also lists 1 linked publication.

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 9 Jan 2025.

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