Rectal CancerPhase 2SPARCNCT05576480
SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer
A Phase 2 study testing Short-course radiotherapy, Penpulimab and CAPEOX in people with Rectal Cancer and Locally Advanced, run by Ruijin Hospital at 1 site in China.
Trial summary
The goal of this phase 2 study is to learn about the efficacy and safety of short-course radiotherapy (SCRT) sequential Penpulimab in combination with CAPEOX in the neoadjuvant treatment of microsatellite stable (MSS) locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Locally Advanced
- What is being tested?
- Short-course radiotherapy, Penpulimab and CAPEOX
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2023to Dec 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
- Informed consent
- 18 years < age ≤ 75 years
- ECOG score is 0-1
- Patients with pathologically confirmed rectal adenocarcinoma, assessed by MRI as mid-low rectal cancer (the lower border of the tumor is less than 10cm from the anal verge), clinical stage II-III (cT1-2N1-2M0 or T3-4N0-2M0) according to the 8th Edition of AJCC Cancer Staging Manual
- Without emergency operation due to complication (bleeding, perforation or obstruction) caused by rectal cancer
- Microsatellite Instability detection using PCR capillary electrophoresis results in MSS
Show all 11Show fewer
- Without any anti-tumor treatment
- No distant metastasis
- Have an imaging measurable or clinically assessable lesion
- Adequate organ and bone marrow function
- Female participants of childbearing age or male participants whose sexual partners are women of childbearing age are required to use effective contraception for the entire treatment period and for 6 months after the end of the treatment period
Who cannot join
- Recurrent rectal cancer
- Previous treatment with pelvic radiotherapy, rectal cancer surgery, chemotherapy, targeted therapy, immune checkpoint inhibitors (including but not limited to PD-1, PD-L1, CTLA-4)
- Proven inability to receive radiotherapy or allergy to the components of Penpulimab, capecitabine, oxaliplatin or their excipients
- Intestinal obstruction due to tumor (except in patients who have received a stoma)
- History of other primary malignancies, except for: malignancies in complete remission for at least 2 years prior to enrolment and not requiring other treatment during the study period; adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease recurrence; adequately treated carcinoma in situ with no evidence of disease recurrence
- Active, known or suspected autoimmune disease or history of this disease within the previous 2 years (patients with vitiligo, psoriasis, alopecia or Graves' disease not requiring systemic treatment within the last 2 years, hypothyroidism requiring only thyroid hormone replacement therapy and type I diabetes requiring only insulin replacement therapy may be enrolled)
Show all 16Show fewer
- Any of the following within 6 months prior to the start of treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association classification II-IV), cerebrovascular event, transient ischaemic attack, severe arrhythmia requiring drug treatment or symptomatic pulmonary embolism
- History of allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation
- Uncontrolled comorbidities including but not limited to: HIV infected; Serious infections that are active or poorly controlled clinically
- Pregnant woman or lactating woman
- Patients who have participated in another drug clinical trial within 4 weeks
- Suffering from acute or chronic active hepatitis B (HBsAg-positive and HBV DNA ≥ 200 IU/mL or ≥ 103 copies/mL) or acute or chronic active hepatitis C (HCV-positive and HCV RNA-positive)
- Received live attenuated vaccine within 4 weeks prior to enrolment or planned during the study period
- Major surgical procedure within 4 weeks prior to enrolment
- History of interstitial pneumonia
- Other acute or chronic diseases, mental disorders, or laboratory test abnormalities that may result in: increasing the risk associated with research participation or drug administration, or interfering with the interpretation of the results of the study, and the patient was classified as not eligible to participate in this study according to the judgment of the researchers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, None Selected, 200025
Ren Zhao, M.D., Ph.D., 86-021-64370045, rjzhaoren@139.com
About this study
Official title: Efficacy and Safety of Short-course Radiotherapy Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of Microsatellite Stable Locally Advanced Rectal Cancer: a Single-centre, Single-arm, Phase 2 Study
The goal of this phase 2 study is to learn about the efficacy and safety of short-course radiotherapy (SCRT) sequential Penpulimab in combination with CAPEOX in the neoadjuvant treatment of microsatellite stable (MSS) locally advanced rectal cancer. The main question it aims to answer is the role of immune checkpoint inhibitors in the neoadjuvant treatment of MSS rectal cancer. Participants will receive neoadjuvant treatment of SCRT sequential Penpulimab in combination with CAPEOX. Participants will undergo a clinical re-staging assessment at the end of neoadjuvant therapy to determine whether to adopt a watch-and-wait strategy or undergo radical surgery.
Read the detailed description
Today there has been an outbreak progress in immunotherapy for tumors, where immune checkpoint inhibitors targeting PD-1/PD-L1 have been approved for the treatment of a variety of tumors, bringing long-term benefits to some patients, especially colorectal cancer and other solid tumors with dMMR/MSI-H have been identified as the best indication population for immunotherapy. However, the majority of patients presented with microsatellite stable (MSS) or pMMR status had a low response rate to immunotherapy. How to improve the response to immunotherapy in these patients has been a challenge in the field of colorectal cancer immunotherapy. A number of preclinical and small clinical studies have identified immunotherapy in combination with other treatments such as chemotherapy, radiotherapy, anti-angiogenic drugs and targeted therapies as potentially viable options to overcome immune resistance and improve the outcome of MSS colorectal cancer. Preclinical and small clinical studies have demonstrated that radiotherapy may induce antigen release from tumors with low neoantigen load and activate dendritic cells, thereby activating CD8+ T lymphocyte-mediated anti-cancer immune responses. In patients with locally advanced rectal cancer, neoadjuvant chemoradiotherapy can increase PD-L1 expression in tumor cells, suggesting that the combination of radiotherapy and PD-1/PD-L1 inhibitors may have a synergistic effect. To further improve the treatment outcomes of locally advanced rectal cancer, we designed an exploratory observational study to observe the efficacy and safety of a regimen of short-course radiotherapy combined with chemotherapy and the addition of the PD-1 monoclonal antibody in locally advanced rectal cancer, and to initially explore the feasibility a watch-and-wait strategy for patients with rectal cancer who have reached pCR.
- Conditions
- Rectal Cancer, Locally Advanced
- Being tested
- Short-course radiotherapy, Penpulimab, CAPEOX, TME surgery
- Keywords
- Immunotherapy, Neoadjuvant Treatment, Locally Advanced Rectal Cancer, Microsatellite stable
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-course radiotherapyRadiation
5×5Gy in Week 1
PenpulimabDrug
Also called PD-1 monoclonal antibody
Apply once in the first week, then every 3 weeks from the third week for four cycles
CAPEOXDrug
Also called Capecitabine and oxaliplatin
Apply every 3 weeks from week 3 for 4 cycles
TME surgeryProcedure or surgery
Patient will receive radical rectal cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| SCRT sequential Penpulimab in combination with CAPEOX | Experimental | * Short-course radiotherapy (SCRT) + one dose of immunotherapy in week 1：Radiotherapy once daily at 5Gy, D1-D5 (5×5Gy); Penpulimab, 200mg, intravenous for 60±5min, D6 or D7.
* Rest at week 2, 4 cycles of chemotherapy (CAPEOX) + immunotherapy from week 3 in cycles of 3 weeks: Capecitabine, 1000 mg/m2 orally, administered twice daily, D1-D14 per cycle; Oxaliplatin, 135 mg/m2, intravenous >2h, administered every cycle D1; Penpulimab, 200 mg, administered intravenously for 60 ± 5 min every cycle D1.
* Clinical re-staging assessment at the end of neoadjuvant therapy allows for a watch-and-wait strategy if cCR is achieved. If any residual lesions remained, radical rectal cancer surgery would be performed at least 2 weeks after the last dose of capecitabine. Whether post-operative adjuvant treatment is performed and the option of post-operative adjuvant treatment is decided by the investigator. Receives: Radiation: Short-course radiotherapy; Drug: Penpulimab; Drug: CAPEOX; Procedure: TME surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete remission rate (pCR)
The proportion of complete remissions detected by postoperative pathological examination (%)
Measured: One month after surgery
Secondary outcomes (7)
Clinical complete remission rate (cCR)
The proportion of complete remissions detected by imaging, endoscopy and digital rectal examination (%)
Measured: Three weeks after neoadjuvant therapy
Objective response rate (ORR)
Sum of proportion in complete and partial remission (%)
Measured: One month after surgery
3-year disease free survival rate (3y-DFS)
3-year disease free survival rate estimated based on Kaplan-Meier method
Measured: 36 months after surgery
R0 resection rate
Histologically complete resection rate (%)
Measured: One month after surgery
Sphincter preservation rate
The proportion of low rectal cancer patients retaining the sphincter in radical surgery (%)
Measured: One month after surgery
Early morbidity rate
Morbidity rate 30 days after surgery (%)
Measured: 30 days after surgery
Number and severity of adverse events
Number and severity of adverse events using CTCAE V5.0
Measured: 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start6 Feb 2023
- Primary completionOct 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- This is a two staged, single arm phase II trial of short-course radiotherapy sequential Penpulimab in combination with CAPEOX in the neoadjuvant treatment of microsatellite stable locally advanced rectal cancer. Twenty-three patients will be enrolled in the first phase and if the number of pathological complete remission is ≤ 3, the trial will be terminated; if \> 3, the trial will proceed to the second phase and continue to enroll up to 48 patients. Taking into account a 15% abscission rate, the total number of patients enrolled will be 55.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Principal investigator, Zhao Ren, Ruijin Hospital
- Investigators
- Ren Zhao, MD, PHD, Principal investigator, Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576480
- Sponsor's protocol ID
- SPARC
- Acronym
- SPARC
- Status last verified
- Aug 2025
- First submitted
- 8 Oct 2022
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bahadoer RR, Dijkstra EA, van Etten B, Marijnen CAM, Putter H, Kranenbarg EM, Roodvoets AGH, Nagtegaal ID, Beets-Tan RGH, Blomqvist LK, Fokstuen T, Ten Tije AJ, Capdevila J, Hendriks MP, Edhemovic I, Cervantes A, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP; RAPIDO collaborative investigators. Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):29-42. doi: 10.1016/S1470-2045(20)30555-6. Epub 2020 Dec 7.
PubMed 33301740Dossa F, Chesney TR, Acuna SA, Baxter NN. A watch-and-wait approach for locally advanced rectal cancer after a clinical complete response following neoadjuvant chemoradiation: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):501-513. doi: 10.1016/S2468-1253(17)30074-2. Epub 2017 May 4.
PubMed 28479372
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Short-course Radiotherapy Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of Microsatellite Stable Locally Advanced Rectal Cancer: a Single-centre, Single-arm, Phase 2 Study
- ClinicalTrials.gov ID
- NCT05576480
- Acronym / sponsor ID
- SPARC / SPARC
- Conditions
- Rectal Cancer, Locally Advanced
- Keywords
- Immunotherapy, Neoadjuvant Treatment, Locally Advanced Rectal Cancer, Microsatellite stable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this phase 2 study is to learn about the efficacy and safety of short-course radiotherapy (SCRT) sequential Penpulimab in combination with CAPEOX in the neoadjuvant treatment of microsatellite stable (MSS) locally advanced rectal cancer. The main question it aims to answer is the role of immune checkpoint inhibitors in the neoadjuvant treatment of MSS rectal cancer. Participants will receive neoadjuvant treatment of SCRT sequential Penpulimab in combination with CAPEOX. Participants will undergo a clinical re-staging assessment at the end of neoadjuvant therapy to determine whether to adopt a watch-and-wait strategy or undergo radical surgery.
Detailed description
Today there has been an outbreak progress in immunotherapy for tumors, where immune checkpoint inhibitors targeting PD-1/PD-L1 have been approved for the treatment of a variety of tumors, bringing long-term benefits to some patients, especially colorectal cancer and other solid tumors with dMMR/MSI-H have been identified as the best indication population for immunotherapy. However, the majority of patients presented with microsatellite stable (MSS) or pMMR status had a low response rate to immunotherapy. How to improve the response to immunotherapy in these patients has been a challenge in the field of colorectal cancer immunotherapy. A number of preclinical and small clinical studies have identified immunotherapy in combination with other treatments such as chemotherapy, radiotherapy, anti-angiogenic drugs and targeted therapies as potentially viable options to overcome immune resistance and improve the outcome of MSS colorectal cancer. Preclinical and small clinical studies have demonstrated that radiotherapy may induce antigen release from tumors with low neoantigen load and activate dendritic cells, thereby activating CD8+ T lymphocyte-mediated anti-cancer immune responses. In patients with locally advanced rectal cancer, neoadjuvant chemoradiotherapy can increase PD-L1 expression in tumor cells, suggesting that the combination of radiotherapy and PD-1/PD-L1 inhibitors may have a synergistic effect. To further improve the treatment outcomes of locally advanced rectal cancer, we designed an exploratory observational study to observe the efficacy and safety of a regimen of short-course radiotherapy combined with chemotherapy and the addition of the PD-1 monoclonal antibody in locally advanced rectal cancer, and to initially explore the feasibility a watch-and-wait strategy for patients with rectal cancer who have reached pCR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a two staged, single arm phase II trial of short-course radiotherapy sequential Penpulimab in combination with CAPEOX in the neoadjuvant treatment of microsatellite stable locally advanced rectal cancer. Twenty-three patients will be enrolled in the first phase and if the number of pathological complete remission is ≤ 3, the trial will be terminated; if > 3, the trial will proceed to the second phase and continue to enroll up to 48 patients. Taking into account a 15% abscission rate, the total number of patients enrolled will be 55.
| Arm | Type | Receives |
|---|---|---|
| SCRT sequential Penpulimab in combination with CAPEOX | Experimental | Radiation: Short-course radiotherapy, Drug: Penpulimab, Drug: CAPEOX, Procedure: TME surgery* Short-course radiotherapy (SCRT) + one dose of immunotherapy in week 1：Radiotherapy once daily at 5Gy, D1-D5 (5×5Gy); Penpulimab, 200mg, intravenous for 60±5min, D6 or D7. * Rest at week 2, 4 cycles of chemotherapy (CAPEOX) + immunotherapy from week 3 in cycles of 3 weeks: Capecitabine, 1000 mg/m2 orally, administered twice daily, D1-D14 per cycle; Oxaliplatin, 135 mg/m2, intravenous >2h, administered every cycle D1; Penpulimab, 200 mg, administered intravenously for 60 ± 5 min every cycle D1. * Clinical re-staging assessment at the end of neoadjuvant therapy allows for a watch-and-wait strategy if cCR is achieved. If any residual lesions remained, radical rectal cancer surgery would be performed at least 2 weeks after the last dose of capecitabine. Whether post-operative adjuvant treatment is performed and the option of post-operative adjuvant treatment is decided by the investigator. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Informed consent
- 18 years < age ≤ 75 years
- ECOG score is 0-1
- Patients with pathologically confirmed rectal adenocarcinoma, assessed by MRI as mid-low rectal cancer (the lower border of the tumor is less than 10cm from the anal verge), clinical stage II-III (cT1-2N1-2M0 or T3-4N0-2M0) according to the 8th Edition of AJCC Cancer Staging Manual
- Without emergency operation due to complication (bleeding, perforation or obstruction) caused by rectal cancer
Key exclusion criteria (16 listed)
- Recurrent rectal cancer
- Previous treatment with pelvic radiotherapy, rectal cancer surgery, chemotherapy, targeted therapy, immune checkpoint inhibitors (including but not limited to PD-1, PD-L1, CTLA-4)
- Proven inability to receive radiotherapy or allergy to the components of Penpulimab, capecitabine, oxaliplatin or their excipients
- Intestinal obstruction due to tumor (except in patients who have received a stoma)
- History of other primary malignancies, except for: malignancies in complete remission for at least 2 years prior to enrolment and not requiring other treatment during the study period; adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease recurrence; adequately treated carcinoma in situ with no evidence of disease recurrence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-course radiotherapy5×5Gy in Week 1 | Radiation | SCRT sequential Penpulimab in combination with CAPEOX |
| PenpulimabAlso: PD-1 monoclonal antibodyApply once in the first week, then every 3 weeks from the third week for four cycles | Drug | SCRT sequential Penpulimab in combination with CAPEOX |
| CAPEOXAlso: Capecitabine and oxaliplatinApply every 3 weeks from week 3 for 4 cycles | Drug | SCRT sequential Penpulimab in combination with CAPEOX |
| TME surgeryPatient will receive radical rectal cancer surgery | Procedure or surgery | SCRT sequential Penpulimab in combination with CAPEOX |
Primary outcome
Pathological complete remission rate (pCR)
Time frame: One month after surgery
The proportion of complete remissions detected by postoperative pathological examination (%)
7 secondary outcomes
Clinical complete remission rate (cCR)
Time frame: Three weeks after neoadjuvant therapy
Objective response rate (ORR)
Time frame: One month after surgery
3-year disease free survival rate (3y-DFS)
Time frame: 36 months after surgery
R0 resection rate
Time frame: One month after surgery
Sphincter preservation rate
Time frame: One month after surgery
Early morbidity rate
Time frame: 30 days after surgery
Number and severity of adverse events
Time frame: 36 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 33301740Bahadoer RR, Dijkstra EA, van Etten B, Marijnen CAM, Putter H, Kranenbarg EM, Roodvoets AGH, Nagtegaal ID, Beets-Tan RGH, Blomqvist LK, Fokstuen T, Ten Tije AJ, Capdevila J, Hendriks MP, Edhemovic I, Cervantes A, Nilsson PJ, Glimelius B, van de Velde CJH, Hospers GAP; RAPIDO collaborative investigators. Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):29-42. doi: 10.1016/S1470-2045(20)30555-6. Epub 2020 Dec 7.
- Background: PubMed 28479372Dossa F, Chesney TR, Acuna SA, Baxter NN. A watch-and-wait approach for locally advanced rectal cancer after a clinical complete response following neoadjuvant chemoradiation: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):501-513. doi: 10.1016/S2468-1253(17)30074-2. Epub 2017 May 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ren Zhao, MD, PHD principal investigator
Ruijin Hospitlal , Shanghai Jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Short-course radiotherapy, Penpulimab and CAPEOX in people with Rectal Cancer and Locally Advanced, run by Ruijin 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 11 inclusion and 16 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 28 Aug 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 Ren Zhao, MD, PHD (+8618917762018, zhaorensurgeon@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete remission rate (pCR) (time frame: One month 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 NCT05576480, which also lists 2 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 28 Aug 2025.