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Microsatellite Stable (MSS) Colon CancerPhase 2mRCAT-CNCT06594692

Node-Sparing Short-Course Radiation With CAPOX and Sintilimab for MSS Locally Advanced Colon Cancer: A Randomized, Prospective, Multicenter Study

A Phase 2 study testing Node-Sparing Short-Course Radiotherapy Combined with CAPOX and Sintilimab and CAPOX Chemotherapy in people with Microsatellite Stable (MSS) Colon Cancer and Locally Advanced Colon Cancer, run by Sir Run Run Shaw Hospital at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study aims to evaluate the use of node-sparing short-course radiotherapy combined with chemotherapy and Sintilimab, or chemotherapy alone, as neoadjuvant therapy for MSS-type locally advanced colon cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Node-Sparing Short-Course Radiotherapy Combined with CAPOX and Sintilimab and CAPOX Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
2 sitesChina
Study dates
Oct 2024to 30 Sep 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients willing to undergo neoadjuvant treatment. 2. Age ≥ 18 years. 3. Tumor confirmed by colonoscopy and enhanced abdominal CT to be ≥ 12 cm from the anal verge.
  • 4. Histologically diagnosed adenocarcinoma; genetic testing indicates MSI-L or MSS, or immunohistochemistry from tumor biopsy shows pMMR (all four proteins-MSH1, MSH2, MSH6, and PMS2-are positive).
  • 5. Clinical staging by enhanced abdominal CT evaluates as cT3-4N0-2M0. 6. ECOG performance status score of 0-1. 7. No prior treatment with anti-tumor, immunotherapy, or abdominal radiation therapy before enrollment.
  • 8. Blood test results (without transfusion within 14 days and no use of granulocyte colony-stimulating factor or other hematopoietic stimulators within 7 days before the lab test):
  • White blood cell count ≥ 3.5 × 10^9/L, absolute neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, hemoglobin concentration ≥ 9 g/dL;
  • Liver function tests (bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 5 × ULN);
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  • Renal function (serum creatinine ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL/min);
  • Coagulation (INR ≤ 1.5 × ULN, PT and APTT ≤ 1.5 × ULN);
  • Thyroid function: TSH ≤ upper limit of normal (ULN); if abnormal, FT3 and FT4 levels must be evaluated, and if FT3 and FT4 are normal, the patient is eligible.
  • 9. Voluntary participation with a signed informed consent form.

Who cannot join

  • 1. History of other malignancies within the past 5 years. 2. Patients with metastases in other locations (stage IV). 3. Patients with MSI-H or dMMR. 4. Patients with conditions such as bowel obstruction, perforation, or bleeding requiring emergency surgery.
  • 5. Known allergy to the study drug or any of its excipients. 6. Patients with any unstable systemic diseases, including but not limited to severe infections, uncontrolled diabetes, uncontrolled hypertension, unstable angina, cerebrovascular accidents or transient ischemic attacks, myocardial infarction, congestive heart failure, or severe illnesses requiring medication (such as arrhythmias, liver, kidney, or metabolic diseases) that are life-threatening.
  • 7. History of active autoimmune diseases requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within the last 2 years. Replacement therapies (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatments.
  • 8. Known history of HIV infection or acquired immunodeficiency syndrome (AIDS). 9. Receipt of any investigational drug (including immunotherapy) or participation in another interventional clinical study within 30 days before screening.
  • 10. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study; men or women unwilling to use effective contraception during the study.
  • 11. Vulnerable populations, including those with mental illness, cognitive impairment, or critically ill patients.
  • 12. Any other conditions deemed inappropriate for participation by the investigator.

Trial locations and contacts

2 sites in 1 country.

Zhangfa Song, Ph.D.;M.D. contact

+86 13867421652

songzhangfa@zju.edu.cn

Engeng Chen, M.D. contact

+86 15258672303

chenengeng@zju.edu.cn

China2 sites

  • Sir Run Run Shaw Hospital, Zhejiang University

    Hangzhou, China, 310016

    Zhangfa Song, Ph.D.;M.D., +86 13867421652, songzhangfa@zju.edu.cn

  • Sir Run Run Shaw Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310016

    chenengeng@zju.edu.cn

Other trials in China

About this study

Official title: Node-sparing Modified Short-Course Radiation Combined With CAPOX and Sintilimab for MSS Locally Advanced Colon Cancer : A Randomized, Prospective, Multicenter, Open-label Clinical Trial

This study aims to evaluate the use of node-sparing short-course radiotherapy combined with chemotherapy and Sintilimab, or chemotherapy alone, as neoadjuvant therapy for MSS-type locally advanced colon cancer. The goal is to explore the efficacy and safety of combining node-sparing short-course radiotherapy with chemotherapy and immunotherapy in the neoadjuvant setting for MSS-type locally advanced colon cancer, while also investigating the specific role of regional lymph nodes in tumor immunotherapy.

Read the detailed description

Colorectal cancer is currently one of the most common malignant tumors in China. According to the latest data released by the National Cancer Center, it ranks second in incidence and fourth in mortality among all cancer types. Statistics indicate that approximately 50% of colon cancer patients in China are in stages II-III. Currently, adjuvant chemotherapy regimens containing oxaliplatin and 5-fluorouracil are the standard treatment for stage III and high-risk stage II colon cancer patients. However, under standard treatment protocols, the 5-year disease-free survival (DFS) rate for stage III colon cancer is less than 64%, with a recurrence rate exceeding 20%. Patients with higher T and N stages face a significantly increased risk of recurrence, severely impacting survival rates and imposing a substantial burden on both the healthcare system and society.

Neoadjuvant chemotherapy, which is administered before surgery, offers several theoretical advantages, including shrinking the primary tumor to improve surgical resection rates, reducing intraoperative tumor cell spread, and eliminating micrometastases and subclinical lesions to lower the risk of postoperative metastasis. However, data on neoadjuvant chemotherapy for locally advanced colon cancer remains limited. The FOxTROT study found that preoperative neoadjuvant chemotherapy significantly reduced the 2-year recurrence rate for locally advanced colon cancer, achieved tumor downstaging, and provided a 4% pathological complete response (pCR) rate. This study also demonstrated a strong correlation between pathological response to neoadjuvant therapy and recurrence risk, with patients achieving pCR or major pathological response (mPR) having significantly lower recurrence rates.

Recent studies have shown that combining immunotherapy with radiotherapy has a synergistic effect, even in MSS-type colorectal cancer patients. Radiotherapy can induce immunogenic cell death, releasing tumor-associated antigens and enhancing the function of dendritic cells, thereby increasing T-cell infiltration. Moreover, chemotherapy can alter the tumor microenvironment, promote angiogenesis, and improve oxygen distribution, further enhancing the efficacy of radiotherapy. One prospective phase II clinical trial involving locally advanced rectal cancer patients showed promising results, with a pCR rate of 46.2% in patients with proficient mismatch repair (pMMR), suggesting a favorable response to neoadjuvant therapy.

Lymph nodes, as secondary lymphoid organs, play a crucial role in tumor diagnosis and treatment. Recent preclinical studies have shown that tumor-draining lymph nodes (TDLNs) are essential in antigen activation and effector T-cell differentiation. On the other hand, tertiary lymphoid structures (TLS), which are organized immune cell aggregates formed in non-lymphoid tissues, have been associated with improved prognosis in cancer patients. However, the role of TDLNs in immunotherapy remains underexplored.

Based on these findings, the research team hypothesizes that tumor-draining lymph nodes play a positive role in immunotherapy response, and sparing these nodes during radiotherapy may enhance the efficacy of immunotherapy for MSS-type colorectal cancer. The team previously conducted a phase II clinical study (NCT04503694) investigating the safety and efficacy of node-sparing short-course radiotherapy combined with CAPOX chemotherapy and PD-1 inhibitors in MSS-type locally advanced rectal cancer. Results showed a 100% response rate to neoadjuvant therapy, with a pCR rate of 78.8% and a major pathological response (mPR) rate of 91%, while maintaining a high rate of organ preservation.

Given the high recurrence rates and treatment challenges associated with locally advanced colon cancer, and building on the promising results of previous studies, the research team intends to conduct the mRCAT-C study. This study aims to explore the clinical efficacy and safety of a node-sparing short-course radiotherapy combined with immunotherapy as a neoadjuvant treatment for MSS-type locally advanced colon cancer.

Being tested
Node-Sparing Short-Course Radiotherapy Combined with CAPOX and Sintilimab, CAPOX Chemotherapy
Keywords
Locally Advanced Colon Cancer, Microsatellite Stable (MSS) Colon Cancer, Node-Sparing Radiotherapy, Short-Course Radiotherapy, Sintilimab
Medical subject headings
Spinocerebellar Degenerations, Colonic Neoplasms

What participants receive

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

  • Node-Sparing Short-Course Radiotherapy Combined with CAPOX and SintilimabDrug

    Radiotherapy Protocol:

    Short-course radiotherapy using three-dimensional conformal or intensity-modulated radiation therapy techniques. The radiation field will be limited to the tumor bed of the primary colon lesion, excluding surrounding draining lymph nodes and enlarged lymph nodes. The dose is fractionated as 5Gy per fraction, for a total of 25Gy over 5 fractions. Titanium clips will be placed on the proximal and distal ends of the colonic lesion via colonoscopy to guide radiation therapy positioning.

    Chemotherapy Protocol (CAPOX Regimen):

    1. Oxaliplatin: 130 mg/m², administered intravenously (ivgtt), on day 1 (d1).
    2. Capecitabine: 1000 mg/m², orally (po), twice daily (bid), from day 1 to day 14 (d1-14).

    Immunotherapy Protocol:

    During preoperative treatment, Sintilimab (immune checkpoint inhibitor) will be administered concurrently with each chemotherapy cycle.

  • CAPOX ChemotherapyDrug

    Participants will receive 4 cycles of CAPOX chemotherapy followed by radical total mesorectal excision surgery, and then 4 additional cycles of postoperative CAPOX chemotherapy.

Study groups in NCT06594692
Study groupRoleWhat they receive
Node-Sparing Short-Course Radiotherapy Combined with CAPOX and SintilimabExperimentalIntervention Procedure: 1. Radiotherapy: Short-course radiotherapy is administered, with a total dose of 25Gy (5Gy per session for 5 sessions) targeting the primary tumor. 2. Chemotherapy and Immunotherapy: On the 8th day after the start of radiotherapy, CAPOX chemotherapy combined with Sintilimab is initiated for 4 cycles. 3. Surgery: One week after the completion of chemotherapy and immunotherapy, patients will undergo radical total mesorectal excision surgery. 4. Postoperative Adjuvant Chemotherapy: Starting 3-4 weeks after surgery, patients will resume CAPOX chemotherapy for an additional 4 cycles as adjuvant treatment.
Receives: Drug: Node-Sparing Short-Course Radiotherapy Combined with CAPOX and Sintilimab
Preoperative CAPOX Regimen as Neoadjuvant TherapyActive comparatorIntervention Procedure: 1. Chemotherapy: Administer CAPOX chemotherapy for 4 cycles. 2. Surgery: One week after the completion of chemotherapy, patients will undergo radical total mesorectal excision surgery. 3. Postoperative Adjuvant Chemotherapy: Starting 3-4 weeks after surgery, patients will resume CAPOX chemotherapy for an additional 4 cycles as adjuvant treatment.
Receives: Drug: CAPOX Chemotherapy

What is being measured

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

  1. pathological complete response rate

    The tumor specimen from node-sparing neoadjuvant chemoradiotherapy combined with immunotherapy, followed by sequential CME (complete mesocolic excision) surgery, showed no presence of cancer cells or lymph node metastasis under microscopic examination (ypT0N0M0).

    Measured: 2 weeks after surgery

Secondary outcomes (10)

  1. R0 resection rate

    which is the percentage of patients who undergo a surgical procedure in which the tumor is completely removed with no cancer cells detected at the margins (edges) of the resected tissue. Achieving an R0 resection is a critical goal in cancer surgery, as it indicates that all visible and microscopic tumor cells have been removed, reducing the likelihood of recurrence.

    Measured: 2 weeks after surgery

  2. Tumor downstaging rate

    The tumor downstaging rate refers to the percentage of patients whose tumors decrease in size or extent (stage) following neoadjuvant treatment, compared to their initial stage at diagnosis. Downstaging means that the tumor has responded to treatment to the point where it moves from a more advanced stage (e.g., from stage III to stage II or I), which may improve the likelihood of successful surgical removal and lead to better prognosis.

    Measured: 2 weeks after surgery

  3. The 3-year Event-Free Survival

    The 3-year Event-Free Survival (EFS) refers to the percentage of patients who remain free from certain negative events-such as cancer progression, recurrence, or death-within three years after treatment. In clinical trials, EFS is a critical measure of a treatment's long-term efficacy, indicating how long patients can live without the disease worsening or other significant events occurring during the follow-up period.

    Measured: 3 years post-treatment

  4. Objective Response Rate

    Objective Response Rate (ORR) refers to the percentage of patients in a clinical study whose cancer shows a measurable reduction in tumor size in response to treatment.

    Measured: 2 weeks after surgery

  5. The 3-year Local Recurrence Rate

    The 3-year Local Recurrence Rate (LRR) refers to the percentage of patients whose cancer returns at the original tumor site or nearby lymph nodes within three years after completing treatment. This measure is important for evaluating the long-term effectiveness of a treatment in preventing the return of cancer in the localized area where it was initially detected. A lower LRR suggests better local control of the disease.

    Measured: 3 years post-treatment

  6. 3-year Disease-Free Survival

    3-year Disease-Free Survival (DFS) refers to the percentage of patients who remain free from any signs or symptoms of cancer for three years after completing treatment. It measures the length of time during which patients experience no recurrence of the disease and are considered to be in remission. DFS is commonly used to assess the effectiveness of a treatment in preventing cancer from returning within a specified time frame.

    Measured: 3 years post-treatment

  7. 3-year Overall Survival

    3-year Overall Survival (OS) refers to the percentage of patients who are still alive three years after the completion of treatment, regardless of whether the cancer has recurred or progressed. It is a key indicator of the effectiveness of a treatment in prolonging life. Unlike Disease-Free Survival (DFS), OS does not take into account whether the disease has returned, focusing solely on survival.

    Measured: 3 years post-treatment

  8. The incidence of grade III/IV adverse events

    The incidence of grade III/IV adverse events refers to the percentage of patients who experience severe or life-threatening side effects (classified as grade III or IV) during a clinical trial. Grade III adverse events are considered serious but not immediately life-threatening, often requiring medical intervention, while grade IV events are life-threatening and typically require urgent medical attention. This measure is crucial for assessing the safety and tolerability of a treatment.

    Measured: 2 weeks after surgery

  9. EORTCQLQ-C30

    The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a standardized tool used to assess the quality of life of cancer patients. It contains 30 questions that cover a wide range of physical, emotional, and social aspects of well-being, including symptoms of cancer and treatment side effects, functioning (physical, role, emotional, cognitive, and social), and overall health. The questionnaire is widely used in clinical trials to evaluate how treatments impact the patient's quality of life during and after treatment.

    Measured: 3 years post-treatment

  10. EORTCQLQ-CR29

    The EORTC QLQ-CR29 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer Module) is a supplementary module to the QLQ-C30 designed specifically to assess quality of life in patients with colorectal cancer. It includes 29 questions that focus on colorectal cancer-specific symptoms and concerns, such as bowel function, body image, and sexual functioning, in addition to the general quality of life issues covered by the QLQ-C30. This questionnaire is used in clinical studies to evaluate the impact of colorectal cancer and its treatment on patients' quality of life.

    Measured: 3 years post-treatment

Timeline

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

  1. First posted19 Sep 2024
  2. Study startOct 2024 (estimated)
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Sep 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06594692
Sponsor's protocol ID
mRCAT-C
Acronym
mRCAT-C
Status last verified
Sep 2024
First submitted
10 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang Q, Zhong W, Shen X, Hao Z, Wan M, Yang X, An R, Zhu H, Cai H, Li T, Lv Y, Dong X, Chen G, Liu A, Du J. Tertiary lymphoid structures predict survival and response to neoadjuvant therapy in locally advanced rectal cancer. NPJ Precis Oncol. 2024 Mar 2;8(1):61. doi: 10.1038/s41698-024-00533-w.

    PubMed 38431733

  • Vanhersecke L, Brunet M, Guegan JP, Rey C, Bougouin A, Cousin S, Moulec SL, Besse B, Loriot Y, Larroquette M, Soubeyran I, Toulmonde M, Roubaud G, Pernot S, Cabart M, Chomy F, Lefevre C, Bourcier K, Kind M, Giglioli I, Sautes-Fridman C, Velasco V, Courgeon F, Oflazoglu E, Savina A, Marabelle A, Soria JC, Bellera C, Sofeu C, Bessede A, Fridman WH, Loarer FL, Italiano A. Mature tertiary lymphoid structures predict immune checkpoint inhibitor efficacy in solid tumors independently of PD-L1 expression. Nat Cancer. 2021 Aug;2(8):794-802. doi: 10.1038/s43018-021-00232-6. Epub 2021 Aug 12.

    PubMed 35118423

  • Rahim MK, Okholm TLH, Jones KB, McCarthy EE, Liu CC, Yee JL, Tamaki SJ, Marquez DM, Tenvooren I, Wai K, Cheung A, Davidson BR, Johri V, Samad B, O'Gorman WE, Krummel MF, van Zante A, Combes AJ, Angelo M, Fong L, Algazi AP, Ha P, Spitzer MH. Dynamic CD8+ T cell responses to cancer immunotherapy in human regional lymph nodes are disrupted in metastatic lymph nodes. Cell. 2023 Mar 16;186(6):1127-1143.e18. doi: 10.1016/j.cell.2023.02.021.

    PubMed 36931243

  • Zhang C, Zhang L, Xu T, Xue R, Yu L, Zhu Y, Wu Y, Zhang Q, Li D, Shen S, Tan D, Bai F, Zhang H. Mapping the spreading routes of lymphatic metastases in human colorectal cancer. Nat Commun. 2020 Apr 24;11(1):1993. doi: 10.1038/s41467-020-15886-6.

    PubMed 32332722

  • Lin Z, Cai M, Zhang P, Li G, Liu T, Li X, Cai K, Nie X, Wang J, Liu J, Liu H, Zhang W, Gao J, Wu C, Wang L, Fan J, Zhang L, Wang Z, Hou Z, Ma C, Yang K, Wu G, Tao K, Zhang T. Phase II, single-arm trial of preoperative short-course radiotherapy followed by chemotherapy and camrelizumab in locally advanced rectal cancer. J Immunother Cancer. 2021 Nov;9(11):e003554. doi: 10.1136/jitc-2021-003554.

    PubMed 34725214

  • Seo I, Lee HW, Byun SJ, Park JY, Min H, Lee SH, Lee JS, Kim S, Bae SU. Neoadjuvant chemoradiation alters biomarkers of anticancer immunotherapy responses in locally advanced rectal cancer. J Immunother Cancer. 2021 Mar;9(3):e001610. doi: 10.1136/jitc-2020-001610.

    PubMed 33692216

  • Theelen WSME, Peulen HMU, Lalezari F, van der Noort V, de Vries JF, Aerts JGJV, Dumoulin DW, Bahce I, Niemeijer AN, de Langen AJ, Monkhorst K, Baas P. Effect of Pembrolizumab After Stereotactic Body Radiotherapy vs Pembrolizumab Alone on Tumor Response in Patients With Advanced Non-Small Cell Lung Cancer: Results of the PEMBRO-RT Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Sep 1;5(9):1276-1282. doi: 10.1001/jamaoncol.2019.1478.

    PubMed 31294749

  • Diaz LA Jr, Shiu KK, Kim TW, Jensen BV, Jensen LH, Punt C, Smith D, Garcia-Carbonero R, Benavides M, Gibbs P, de la Fourchardiere C, Rivera F, Elez E, Le DT, Yoshino T, Zhong WY, Fogelman D, Marinello P, Andre T; KEYNOTE-177 Investigators. Pembrolizumab versus chemotherapy for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer (KEYNOTE-177): final analysis of a randomised, open-label, phase 3 study. Lancet Oncol. 2022 May;23(5):659-670. doi: 10.1016/S1470-2045(22)00197-8. Epub 2022 Apr 12.

    PubMed 35427471

  • Cercek A, Lumish M, Sinopoli J, Weiss J, Shia J, Lamendola-Essel M, El Dika IH, Segal N, Shcherba M, Sugarman R, Stadler Z, Yaeger R, Smith JJ, Rousseau B, Argiles G, Patel M, Desai A, Saltz LB, Widmar M, Iyer K, Zhang J, Gianino N, Crane C, Romesser PB, Pappou EP, Paty P, Garcia-Aguilar J, Gonen M, Gollub M, Weiser MR, Schalper KA, Diaz LA Jr. PD-1 Blockade in Mismatch Repair-Deficient, Locally Advanced Rectal Cancer. N Engl J Med. 2022 Jun 23;386(25):2363-2376. doi: 10.1056/NEJMoa2201445. Epub 2022 Jun 5.

    PubMed 35660797

  • Yuan Y, Xiao WW, Xie WH, Cai PQ, Wang QX, Chang H, Chen BQ, Zhou WH, Zeng ZF, Wu XJ, Liu Q, Li LR, Zhang R, Gao YH. Neoadjuvant chemoradiotherapy for patients with unresectable radically locally advanced colon cancer: a potential improvement to overall survival and decrease to multivisceral resection. BMC Cancer. 2021 Feb 19;21(1):179. doi: 10.1186/s12885-021-07894-6.

    PubMed 33607964

  • Chang H, Yu X, Xiao WW, Wang QX, Zhou WH, Zeng ZF, Ding PR, Li LR, Gao YH. Neoadjuvant chemoradiotherapy followed by surgery in patients with unresectable locally advanced colon cancer: a prospective observational study. Onco Targets Ther. 2018 Jan 17;11:409-418. doi: 10.2147/OTT.S150367. eCollection 2018.

    PubMed 29398921

  • Qiu B, Ding PR, Cai L, Xiao WW, Zeng ZF, Chen G, Lu ZH, Li LR, Wu XJ, Mirimanoff RO, Pan ZZ, Xu RH, Gao YH. Outcomes of preoperative chemoradiotherapy followed by surgery in patients with unresectable locally advanced sigmoid colon cancer. Chin J Cancer. 2016 Jul 7;35(1):65. doi: 10.1186/s40880-016-0126-y.

    PubMed 27389519

  • Ludmir EB, Arya R, Wu Y, Palta M, Willett CG, Czito BG. Role of Adjuvant Radiotherapy in Locally Advanced Colonic Carcinoma in the Modern Chemotherapy Era. Ann Surg Oncol. 2016 Mar;23(3):856-62. doi: 10.1245/s10434-015-4907-3. Epub 2015 Oct 19.

    PubMed 26480849

  • Agas RAF, Co LBA, Sogono PG, Jacinto JCKM, Yu KKL, Jacomina LE, Bacorro WR, Sy Ortin TT. Assessing the Effect of Radiotherapy in Addition to Surgery in Colon Adenocarcinomas: a Systematic Review and Meta-analysis of Contemporary Evidence. J Gastrointest Cancer. 2020 Jun;51(2):445-460. doi: 10.1007/s12029-019-00300-2.

    PubMed 31463890

  • Fernandez LM, Sao Juliao GP, Figueiredo NL, Beets GL, van der Valk MJM, Bahadoer RR, Hilling DE, Meershoek-Klein Kranenbarg E, Roodvoets AGH, Renehan AG, van de Velde CJH, Habr-Gama A, Perez RO; International Watch & Wait Database Consortium. Conditional recurrence-free survival of clinical complete responders managed by watch and wait after neoadjuvant chemoradiotherapy for rectal cancer in the International Watch & Wait Database: a retrospective, international, multicentre registry study. Lancet Oncol. 2021 Jan;22(1):43-50. doi: 10.1016/S1470-2045(20)30557-X. Epub 2020 Dec 11.

    PubMed 33316218

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Node-Sparing Short-Course Radiotherapy Combined with CAPOX and Sintilimab and CAPOX Chemotherapy in people with Microsatellite Stable (MSS) Colon Cancer and Locally Advanced Colon Cancer, run by Sir Run Run Shaw Hospital at 2 sites 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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhangfa Song, Ph.D.;M.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 rate (time frame: 2 weeks 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 NCT06594692, which also lists 24 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 19 Sep 2024.

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