Rectal Cancer PatientsPhase 2NCT07663071
Short-course Radiotherapy Combined With Retlirafusp Alfa and CAPOX Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Prospective, Single-arm, Phase II Clinical Study
A Phase 2 study testing Short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy in people with Rectal Cancer Patients, run by Harbin Medical University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of neoadjuvant short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy in the treatment of locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Cancer Patients
- What is being tested?
- Short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2026to 27 May 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years, male or female.
- Histologically or cytologically confirmed rectal adenocarcinoma, stage T3N+M0 or T4NanyM0 (AJCC/UICC TNM 8th edition), with measurable lesion(s) per RECIST 1.1.
- Tumor lower border 5-10 cm from the anal verge.
- Expected to achieve R0 resection after neoadjuvant therapy, and planned for surgery thereafter.
- ECOG PS 0-1.
- No prior anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, immune checkpoint inhibitors, or surgery.
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- Adequate organ function (without blood product or growth factor support during screening):
- ANC ≥1.5×10⁹/L; platelets ≥100×10⁹/L; hemoglobin ≥8.5 g/dL.
- TSH ≤1×ULN (if abnormal, T3/T4 must be within normal limits for enrollment).
- Bilirubin ≤1.5×ULN; ALT and AST ≤2.5×ULN.
- Serum creatinine ≤1.5×ULN or CrCl ≥50 mL/min (Cockcroft-Gault formula).
- INR ≤1.5×ULN; APTT ≤1.5×ULN.
- Negative pregnancy test (β-hCG) for women of childbearing potential before treatment initiation.Women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception continuously during treatment and for 6 months after the last dose.
- Voluntary participation with written informed consent.
Who cannot join
- History of other malignancies within the past 5 years, except adequately treated cervical carcinoma in situ, cutaneous squamous cell carcinoma, or basal cell carcinoma.
- Major surgery or severe trauma within 4 weeks prior to first study drug administration.
- Systemic corticosteroids (equivalent to prednisone >10 mg/day) or other immunosuppressive therapy within 2 weeks prior to study drug administration.
- Active, known, or suspected autoimmune disease. Patients with stable conditions not requiring systemic immunosuppression (e.g., type 1 diabetes, hypothyroidism on hormone replacement, or skin disorders without systemic treatment) are eligible.
- Immunodeficiency, including HIV positivity, other acquired/congenital immune deficiencies, or history of organ or allogeneic bone marrow transplantation.
- Congestive heart failure, uncontrolled arrhythmia, myocardial infarction within 6 months, unstable angina, stroke, or other conditions precluding surgery.
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- Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired pulmonary function.
- Uncontrolled symptomatic brain metastases, poorly controlled psychiatric disorders, or severe intellectual/cognitive impairment.
- Known substance abuse or drug addiction.
- Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment.
- Severe active infection requiring IV antibiotics during screening.
- Known hypersensitivity to Retlirafusp alfa or any excipients (polysorbate 80 (II), sucrose, citric acid, sodium citrate, water for injection, etc.), or severe allergic reactions to other monoclonal antibodies.
- Active hepatitis B (HBV DNA >2000 IU/mL or 10⁴ copies/mL), or hepatitis C antibody-positive with HCV RNA above the lower limit of detection.
- Receipt or planned receipt of live vaccine within 30 days prior to immunotherapy administration.
- Intolerance to chemotherapy.
- Inability to comply with the protocol or follow-up.
- Other conditions deemed unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Harbin Medical University Cancer Hospital, No. 150 Haping Road, Nangang District, Harbin, Heilongjiang Province, China
Harbin, Heilongjiang, 150081
About this study
This study aims to evaluate the efficacy and safety of neoadjuvant short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy in the treatment of locally advanced rectal cancer. This is a prospective, single-arm, phase II clinical trial planned to enroll 44 patients with locally advanced rectal cancer. The primary endpoint is the complete response rate, and secondary endpoints include objective response rate, pathological complete response rate, event-free survival, and overall survival, with the goal of providing evidence to optimize clinical treatment decisions.
Read the detailed description
The standard treatment for locally advanced rectal cancer (LARC) is neoadjuvant chemoradiotherapy followed by total mesorectal excision. However, the pathological complete response rate of the traditional regimen is only 10%-15%, and the distant metastasis rate remains high, which falls short of clinical needs. In recent years, immune checkpoint inhibitors have demonstrated significant efficacy in various malignancies. However, microsatellite-stable (MSS) colorectal cancer responds poorly to immunotherapy monotherapy and is therefore considered a "cold tumor." Preclinical and clinical studies suggest that radiotherapy can enhance immune responses by remodeling the tumor microenvironment and promoting tumor antigen release, thereby exerting synergistic antitumor effects when combined with immunotherapy. In addition, the TGF-β signaling pathway plays an important role in immune evasion in colorectal cancer, and bifunctional fusion proteins that simultaneously target PD-L1 and TGF-β are expected to more effectively restore T-cell activity. Based on these findings, this study innovatively combines short-course radiotherapy, Retlirafusp alfa (an anti-PD-L1/TGF-βRII bifunctional fusion protein), and the CAPOX chemotherapy regimen as neoadjuvant therapy for locally advanced rectal cancer.This study plans to enroll 44 patients with previously untreated locally advanced rectal cancer (T3N+M0 or T4NanyM0, AJCC 8th edition). The treatment regimen consists of short-course radiotherapy (25 Gy/5 fractions, D2-D6) combined with Retlirafusp alfa and CAPOX chemotherapy in the first cycle, followed by Retlirafusp alfa plus CAPOX chemotherapy in cycles 2 through 4. Efficacy evaluations will be performed after cycles 2 and 4, respectively. Patients who achieve clinical complete response may opt for a watch-and-wait strategy, while those who do not are recommended to undergo total mesorectal excision. The primary endpoint is the complete response rate (cCR + pCR). Secondary endpoints include objective response rate, pathological complete response rate, major pathological response, tumor regression grade,event-free survival, overall survival, safety, and changes in patient quality of life and anal function. The conduct of this study will provide important evidence on the efficacy and safety of the "short-course radiotherapy + immunotherapy + chemotherapy" neoadjuvant treatment model for locally advanced rectal cancer, with the potential to offer patients greater opportunities for organ preservation and improved long term survival.
- Conditions
- Rectal Cancer Patients
- Being tested
- Short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy
- Keywords
- locally advanced rectal cancer, Retlirafusp alfa, neoadjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapyDrug
Short-course radiotherapy + Retlirafusp alfa + CAPOX chemotherapy for 1 cycle, followed by Retlirafusp alfa + CAPOX chemotherapy for 3 cycles.
Cycle 1:
Retlirafusp alfa: 1800 mg or 30 mg/kg, IV infusion over 30-60 min, D1, q3w; administered at least 30 min before chemotherapy.
Oxaliplatin: 130 mg/m², IV infusion over ≥2 h, D1, q3w.
Capecitabine: 1000 mg/m², PO, twice daily (total 2000 mg/m²/day) for 14 days, q3w.
Short-course radiotherapy: 25 Gy in 5 fractions, D2-D6.
Cycles 2-4:
Retlirafusp alfa: 1800 mg or 30 mg/kg, IV infusion over 30-60 min, D1, q3w.
Oxaliplatin: 130 mg/m², IV infusion over ≥2 h, D1, q3w.
Capecitabine: 1000 mg/m², PO, twice daily (total 2000 mg/m²/day) for 14 days, q3w.
Efficacy evaluation is performed after cycles 2 and 4. Patients are reassessed 2-4 weeks after the last treatment. Those achieving clinical complete response (cCR) may opt for watch-and-wait (W\&W). Non-cCR patients (near-CR, PR, or SD) are recommended to undergo total mesorectal excision (
| Study group | Role | What they receive |
|---|---|---|
| Short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy | Experimental | Short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy Receives: Drug: Short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (cCR+pCR)
Proportion of patients achieving clinical complete response (cCR, no tumor residue by imaging and endoscopy) after neoadjuvant therapy or pathological complete response (pCR, no residual viable tumor cells in tumor bed) post-surgery, reflecting overall tumor eradication.
Measured: cCR assessed 2-4 weeks post-neoadjuvant therapy; pCR assessed within 2 weeks post-surgery; follow-up up to ~6 months.
Secondary outcomes (11)
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria on imaging.
Measured: Imaging assessment after cycles 2 and 4, and post-surgery; follow-up up to ~6 months.
Pathological Complete Response (pCR)
Proportion of patients with no residual viable tumor cells in the tumor bed (ypT0N0) after neoadjuvant therapy and surgery.
Measured: Pathological assessment within 2 weeks post-surgery; follow-up up to ~6 months.
Major Pathological Response (MPR)
Proportion of patients with ≤10% residual viable tumor cells in the tumor bed post-surgery.
Measured: Pathological assessment within 2 weeks post-surgery; follow-up up to ~6 months.
TRG Grade
Assessment of pathological tumor regression grade (TRG 0-3) per AJCC 8th edition.
Measured: Pathological assessment within 2 weeks post-surgery; follow-up up to ~6 months.
Event-Free Survival (EFS)
Time from treatment initiation to first occurrence of: disease progression (local/distant) during neoadjuvant therapy, treatment discontinuation (toxicity/patient withdrawal), local/distant recurrence, new primary tumor, or death from any cause.
Measured: From treatment initiation to first event, follow-up every 3 months, up to 36 months.
Overall Survival (OS)
Time from first dose to death from any cause (censored at last follow-up for alive or lost patients).
Measured: From first dose to death or last follow-up, follow-up every 3 months, up to 36 months.
Adverse Event Rate
Incidence and severity of adverse events per NCI CTCAE 6.0; surgical complications graded per Clavien-Dindo classification.
Measured: Continuous monitoring from informed consent to 90 days post-last dose; follow-up up to ~36 months.
Quality of Life (EORTC QLQ-CR29)
Assessment of bowel symptoms, sexual function, and overall quality of life; higher scores indicate worse symptoms or better function.
Measured: Assessed at baseline, pre-surgery post-neoadjuvant therapy, and 3, 6, 12 months post-surgery; follow-up up to 12 months.
Anal Function (LARS Score)
Assessment of low anterior resection syndrome, total score 0-42 (0-20: no/mild LARS; 21-29: moderate; 30-42: severe).
Measured: Assessed at baseline, pre-surgery post-neoadjuvant therapy, and 3, 6, 12 months post-surgery; follow-up up to 12 months.
Emotional Changes (GAD-7)
Assessment of anxiety status during treatment, total score 0-21; ≥10 indicates moderate-to-severe anxiety.
Measured: Generalized Anxiety Disorder Scale (GAD-7) assessed with a maximum follow-up of 12 months.
Biomarker Exploration
Collection of tumor tissue and peripheral blood samples for genomic, transcriptomic, proteomic, and immune microenvironment analyses to identify potential predictive and prognostic biomarkers associated with efficacy and safety.
Measured: Tumor tissue and peripheral blood collected at baseline; peripheral blood collected periodically during treatment; follow-up up to ~6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start27 May 2026
- Primary completion27 May 2028 (estimated)
- Study completion27 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer PatientsStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Peng, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663071
- Sponsor's protocol ID
- SHR-1701-HLJ-001
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-course Radiotherapy Combined With Retlirafusp Alfa and CAPOX Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Prospective, Single-arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07663071
- Acronym / sponsor ID
- SHR-1701-HLJ-001
- Conditions
- Rectal Cancer Patients
- Keywords
- locally advanced rectal cancer, Retlirafusp alfa, neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 27 May 2026 (actual)
- Primary completion
- 27 May 2028 (estimated)
- Study completion
- 27 May 2029 (estimated)
- First posted
- 23 Jun 2026 (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.
This study aims to evaluate the efficacy and safety of neoadjuvant short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy in the treatment of locally advanced rectal cancer. This is a prospective, single-arm, phase II clinical trial planned to enroll 44 patients with locally advanced rectal cancer. The primary endpoint is the complete response rate, and secondary endpoints include objective response rate, pathological complete response rate, event-free survival, and overall survival, with the goal of providing evidence to optimize clinical treatment decisions.
Detailed description
The standard treatment for locally advanced rectal cancer (LARC) is neoadjuvant chemoradiotherapy followed by total mesorectal excision. However, the pathological complete response rate of the traditional regimen is only 10%-15%, and the distant metastasis rate remains high, which falls short of clinical needs. In recent years, immune checkpoint inhibitors have demonstrated significant efficacy in various malignancies. However, microsatellite-stable (MSS) colorectal cancer responds poorly to immunotherapy monotherapy and is therefore considered a "cold tumor." Preclinical and clinical studies suggest that radiotherapy can enhance immune responses by remodeling the tumor microenvironment and promoting tumor antigen release, thereby exerting synergistic antitumor effects when combined with immunotherapy. In addition, the TGF-β signaling pathway plays an important role in immune evasion in colorectal cancer, and bifunctional fusion proteins that simultaneously target PD-L1 and TGF-β are expected to more effectively restore T-cell activity. Based on these findings, this study innovatively combines short-course radiotherapy, Retlirafusp alfa (an anti-PD-L1/TGF-βRII bifunctional fusion protein), and the CAPOX chemotherapy regimen as neoadjuvant therapy for locally advanced rectal cancer.This study plans to enroll 44 patients with previously untreated locally advanced rectal cancer (T3N+M0 or T4NanyM0, AJCC 8th edition). The treatment regimen consists of short-course radiotherapy (25 Gy/5 fractions, D2-D6) combined with Retlirafusp alfa and CAPOX chemotherapy in the first cycle, followed by Retlirafusp alfa plus CAPOX chemotherapy in cycles 2 through 4. Efficacy evaluations will be performed after cycles 2 and 4, respectively. Patients who achieve clinical complete response may opt for a watch-and-wait strategy, while those who do not are recommended to undergo total mesorectal excision. The primary endpoint is the complete response rate (cCR + pCR). Secondary endpoints include objective response rate, pathological complete response rate, major pathological response, tumor regression grade,event-free survival, overall survival, safety, and changes in patient quality of life and anal function. The conduct of this study will provide important evidence on the efficacy and safety of the "short-course radiotherapy + immunotherapy + chemotherapy" neoadjuvant treatment model for locally advanced rectal cancer, with the potential to offer patients greater opportunities for organ preservation and improved long term survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy | Experimental | Drug: Short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapyShort-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 18-70 years, male or female.
- Histologically or cytologically confirmed rectal adenocarcinoma, stage T3N+M0 or T4NanyM0 (AJCC/UICC TNM 8th edition), with measurable lesion(s) per RECIST 1.1.
- Tumor lower border 5-10 cm from the anal verge.
- Expected to achieve R0 resection after neoadjuvant therapy, and planned for surgery thereafter.
- ECOG PS 0-1.
Key exclusion criteria (17 listed)
- History of other malignancies within the past 5 years, except adequately treated cervical carcinoma in situ, cutaneous squamous cell carcinoma, or basal cell carcinoma.
- Major surgery or severe trauma within 4 weeks prior to first study drug administration.
- Systemic corticosteroids (equivalent to prednisone >10 mg/day) or other immunosuppressive therapy within 2 weeks prior to study drug administration.
- Active, known, or suspected autoimmune disease. Patients with stable conditions not requiring systemic immunosuppression (e.g., type 1 diabetes, hypothyroidism on hormone replacement, or skin disorders without systemic treatment) are eligible.
- Immunodeficiency, including HIV positivity, other acquired/congenital immune deficiencies, or history of organ or allogeneic bone marrow transplantation.
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 radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapyShort-course radiotherapy + Retlirafusp alfa + CAPOX chemotherapy for 1 cycle, followed by Retlirafusp alfa + CAPOX chemotherapy for 3 cycles. Cycle 1: Retlirafusp alfa: 1800 mg or 30 mg/kg, IV infusion over 30-60 min, D1, q3w; administered at least 30 min before chemotherapy. Oxaliplatin: 130 mg/m², IV infusion over ≥2 h, D1, q3w. Capecitabine: 1000 mg/m², PO, twice daily (total 2000 mg/m²/day) for 14 days, q3w. Short-course radiotherapy: 25 Gy in 5 fractions, D2-D6. Cycles 2-4: Retlirafusp alfa: 1800 mg or 30 mg/kg, IV infusion over 30-60 min, D1, q3w. Oxaliplatin: 130 mg/m², IV infusion over ≥2 h, D1, q3w. Capecitabine: 1000 mg/m², PO, twice daily (total 2000 mg/m²/day) for 14 days, q3w. Efficacy evaluation is performed after cycles 2 and 4. Patients are reassessed 2-4 weeks after the last treatment. Those achieving clinical complete response (cCR) may opt for watch-and-wait (W\&W). Non-cCR patients (near-CR, PR, or SD) are recommended to undergo total mesorectal excision ( | Drug | Short-course radiotherapy combined with Retlirafusp alfa and CAPOX chemotherapy |
Primary outcome
Complete Response Rate (cCR+pCR)
Time frame: cCR assessed 2-4 weeks post-neoadjuvant therapy; pCR assessed within 2 weeks post-surgery; follow-up up to ~6 months.
Proportion of patients achieving clinical complete response (cCR, no tumor residue by imaging and endoscopy) after neoadjuvant therapy or pathological complete response (pCR, no residual viable tumor cells in tumor bed) post-surgery, reflecting overall tumor eradication.
11 secondary outcomes
Objective Response Rate (ORR)
Time frame: Imaging assessment after cycles 2 and 4, and post-surgery; follow-up up to ~6 months.
Pathological Complete Response (pCR)
Time frame: Pathological assessment within 2 weeks post-surgery; follow-up up to ~6 months.
Major Pathological Response (MPR)
Time frame: Pathological assessment within 2 weeks post-surgery; follow-up up to ~6 months.
TRG Grade
Time frame: Pathological assessment within 2 weeks post-surgery; follow-up up to ~6 months.
Event-Free Survival (EFS)
Time frame: From treatment initiation to first event, follow-up every 3 months, up to 36 months.
Overall Survival (OS)
Time frame: From first dose to death or last follow-up, follow-up every 3 months, up to 36 months.
Adverse Event Rate
Time frame: Continuous monitoring from informed consent to 90 days post-last dose; follow-up up to ~36 months.
Quality of Life (EORTC QLQ-CR29)
Time frame: Assessed at baseline, pre-surgery post-neoadjuvant therapy, and 3, 6, 12 months post-surgery; follow-up up to 12 months.
Anal Function (LARS Score)
Time frame: Assessed at baseline, pre-surgery post-neoadjuvant therapy, and 3, 6, 12 months post-surgery; follow-up up to 12 months.
Emotional Changes (GAD-7)
Time frame: Generalized Anxiety Disorder Scale (GAD-7) assessed with a maximum follow-up of 12 months.
Biomarker Exploration
Time frame: Tumor tissue and peripheral blood collected at baseline; peripheral blood collected periodically during treatment; follow-up up to ~6 months.
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 23 Jun 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 combined with Retlirafusp alfa and CAPOX chemotherapy in people with Rectal Cancer Patients, run by Harbin Medical University 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 14 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (cCR+pCR) (time frame: cCR assessed 2-4 weeks post-neoadjuvant therapy; pCR assessed within 2 weeks post-surgery; follow-up up to ~6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2026.