Rectal NeoplasmsPhase 2TRIP-FASTNCT07888309
SCRT + Fruquintinib + Tislelizumab + CAPOX Versus SCRT + Tislelizumab + CAPOX as Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer
A Phase 2 study testing Short-Course Radiotherapy, Fruquintinib and Tislelizumab in people with Rectal Neoplasms and Rectal Cancer, Adenocarcinoma, run by Ruijin Hospital at 1 site in China.
Trial summary
The goal of this randomized controlled clinical trial is to learn if adding fruquintinib to short-course radiotherapy, tislelizumab, and CAPOX can improve neoadjuvant treatment response and is safe for adults with locally advanced low rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasms, Rectal Cancer, Adenocarcinoma
- What is being tested?
- Short-Course Radiotherapy, Fruquintinib and Tislelizumab
- 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
- 50 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2025to 11 Sep 2030
- 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
- Has voluntarily signed a written informed consent form before any study-specific procedures.
- Age 18 to 75 years (inclusive), with no restriction on sex.
- Histologically confirmed locally advanced rectal adenocarcinoma by biopsy.
- Pelvic MRI shows high-risk features, meeting any one of the following:
- Clinical tumor (cT) stage cT4a or cT4b (per AJCC 8th edition);
- Extramural venous invasion (EMVI);
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- Clinical nodal (cN) stage cN2 (per AJCC 8th edition);
- Involvement of the mesorectal fascia (MRF);
- Enlarged lateral lymph nodes.
- The inferior margin of the tumor is ≤ 10 cm from the anal verge.
- Able to swallow tablets and capsules normally.
- ECOG performance status 0-1.
- No prior anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, or surgery.
- Planned to undergo surgical treatment after completion of neoadjuvant therapy.
- No contraindications to surgery.
- Adequate function of major organs, including:
- Hematology (no blood or blood-product transfusion, and no use of G-CSF or other hematopoietic growth factors for correction within 14 days before the first treatment): absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count ≥ 75 × 10⁹/L; hemoglobin ≥ 90 g/L; white blood cell count ≥ 3.0 × 10⁹/L;
- Blood chemistry: total bilirubin ≤ 1.5 × ULN (for subjects with Gilbert's syndrome, ≤ 3 × ULN; for those with liver metastases, total bilirubin ≤ 3 × ULN); ALT ≤ 2.5 × ULN and AST ≤ 2.5 × ULN (for those with liver metastases, ≤ 5 × ULN); serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min ;
- Coagulation: International Normalized Ratio (INR) ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; prothrombin time (PT) ≤ 1.5 × ULN;
- Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
- Female subjects of childbearing potential must have a serum pregnancy test within 14 days before the first study drug administration, with a negative result, and must use effective contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for at least 6 months after the last dose. Male subjects whose partners are women of childbearing potential must use effective contraception during the study and for 6 months after the last dose.
Who cannot join
- History of allergy to any anti-angiogenic targeted drug, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-containing agents.
- Has received or is receiving any of the following treatments:
- Use of immunosuppressive agents or systemic corticosteroids for immunosuppression within 2 weeks before the first study drug administration (dose > 10 mg/day prednisone or equivalent); inhaled or topical steroids and adrenal corticosteroid replacement at doses > 10 mg/day prednisone equivalent are permitted in the absence of active autoimmune disease;
- Receipt of a live attenuated vaccine within 4 weeks before the first study drug administration;
- Major surgery or severe trauma within 4 weeks before the first study drug administration.
- Any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for enrollment after hormone replacement therapy); subjects with psoriasis or childhood asthma/allergy that has completely resolved and requires no intervention after adulthood may be considered for enrollment, but those requiring bronchodilator medical intervention are excluded.
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- History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.
- Uncontrolled cardiac clinical symptoms or diseases, including but not limited to: (1) heart failure of NYHA class II or higher, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia that remains uncontrolled with or without clinical intervention, (5) hypertension not well controlled by a single antihypertensive agent (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg) or requiring two or more antihypertensive agents, (6) New York Heart Association (NYHA) cardiac function class > II or left ventricular ejection fraction (LVEF) < 50%.
- Severe infection (CTCAE > grade 2) within 4 weeks before the first study drug administration, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; active pulmonary inflammation on baseline chest imaging, or signs/symptoms of infection or need for oral/intravenous antibiotics within 14 days before the first study drug administration, except for prophylactic antibiotic use.
- Active pulmonary tuberculosis infection identified by history or CT, or history of active pulmonary tuberculosis within 1 year before enrollment, or history of active pulmonary tuberculosis more than 1 year ago without standard treatment.
- Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), or hepatitis C (positive anti-HCV antibody and HCV RNA above the lower limit of detection of the assay).
- Presence of a second primary malignancy.
- Pregnant or lactating women.
- Arterial or venous thrombotic events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism.
- History of substance abuse that cannot be discontinued, or psychiatric disorders.
- Any signs or history of bleeding diathesis, regardless of severity.
- Patients with active bleeding or a tendency to bleed indicating high bleeding risk.
- Urinalysis showing proteinuria ≥ ++, confirmed by 24-hour urine protein quantification > 1.0 g.
- As judged by the investigator, other factors that may lead to forced discontinuation of the study, such as other serious diseases (including psychiatric disorders) requiring concomitant treatment, alcoholism, drug abuse, family or social factors, or any factor that may affect the subject's safety or compliance.
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
Shanghai Jiaotong Univeristy School of Medicine Affiliated Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Pei Xue, 86-21-64370045, xuepei0415@163.com
Pei Xue, PhD
About this study
Official title: Short-Course Radiotherapy Followed by Fruquintinib Plus Tislelizumab and CAPOX Versus Short-Course Radiotherapy Followed by Tislelizumab and CAPOX for Neoadjuvant Treatment of Locally Advanced Low Rectal Cancer: A Randomized Controlled Trial
The goal of this randomized controlled clinical trial is to learn if adding fruquintinib to short-course radiotherapy, tislelizumab, and CAPOX can improve neoadjuvant treatment response and is safe for adults with locally advanced low rectal cancer. The main questions it aims to answer are:
- Does adding fruquintinib increase the pathological complete response (pCR) rate after neoadjuvant therapy?
- What adverse events do participants experience when fruquintinib is added to the regimen? Researchers will compare short-course radiotherapy followed by fruquintinib + tislelizumab + CAPOX with short-course radiotherapy followed by tislelizumab + CAPOX to see if adding fruquintinib improves the tumor response to neoadjuvant treatment.
Read more
Participants will:
- Receive short-course radiotherapy (e.g., 25 Gy in 5 daily fractions over 1 week)
- Receive either fruquintinib + tislelizumab + CAPOX (experimental arm) or tislelizumab + CAPOX (control arm) for the neoadjuvant cycles
- Attend scheduled visits for tumor assessment (MRI, endoscopy, CT), blood tests, and adverse-event monitoring
- Undergo total mesorectal excision (TME) surgery after neoadjuvant treatment and have the specimen evaluated for pathological response
Read the detailed description
Background Locally advanced rectal cancer is cancer of the rectum that has grown deeply into the bowel wall or into nearby tissues or lymph nodes, but has not yet spread to distant organs. When the tumor sits in the lower part of the rectum, the standard operation to remove it can put the muscles that control bowel continence at risk, sometimes requiring a permanent colostomy (a surgical opening of the intestine to the abdominal wall). To reduce this risk, doctors often give treatment before surgery - called neoadjuvant (preoperative) therapy - with the goal of shrinking the tumor, increasing the chance that no cancer remains, and preserving the patient's natural bowel function.
Current neoadjuvant approaches A widely used strategy is short-course radiotherapy (a brief, intensified course of pelvic radiation) followed by chemotherapy, and increasingly by immunotherapy. Radiotherapy and chemotherapy kill cancer cells directly, while immunotherapy helps the patient's own immune system recognize and attack the tumor. Combining all three - radiation, immune-based therapy, and chemotherapy - is an active and promising direction in rectal cancer care.
Why this study is being done Not every patient's tumor responds completely to existing neoadjuvant treatment, and some still require extensive surgery or a permanent stoma. This study tests whether adding a drug called fruquintinib - which starves the tumor by blocking VEGF receptors that fuel its blood supply - to the combination of short-course radiotherapy, the immunotherapy tislelizumab, and the chemotherapy CAPOX, can improve the likelihood that no living cancer cells remain in the tissue removed at surgery. Cutting off a tumor's blood supply may also make immunotherapy and chemotherapy work more effectively.
What participating means People who join this randomized trial are assigned by chance to one of two treatment plans. Both groups receive the same short-course radiotherapy followed by tislelizumab and CAPOX chemotherapy; the experimental group additionally receives fruquintinib. Treatment is given before surgery. After the neoadjuvant phase, standard rectal cancer surgery is performed and the removed specimen is examined for how much cancer remains. Throughout the study, participants have regular imaging, endoscopy, and blood-test assessments and are closely monitored for side effects.
Study aims The central question is whether adding fruquintinib increases the rate of pathological complete response - meaning the surgical specimen shows no remaining viable tumor - and whether the added drug is tolerable. A higher complete-response rate could mean more patients are able to keep their bowel function and avoid a permanent stoma.
Why it matters If the experimental combination proves more effective and acceptable, it could offer a new neoadjuvant option for people with locally advanced low rectal cancer who hope to preserve bowel function. The results will also help show whether blocking a tumor's blood supply alongside immune-based and chemical treatment is a useful strategy in this disease.
- Conditions
- Rectal Neoplasms, Rectal Cancer, Adenocarcinoma
- Being tested
- Short-Course Radiotherapy, Fruquintinib, Tislelizumab, CAPOX
- Keywords
- Short-course radiotherapy, Fruquintinib, Tislelizumab, CAPOX, Neoadjuvant therapy, Locally advanced low rectal cancer, Pathological complete response
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-Course RadiotherapyRadiation
Preoperative pelvic external-beam radiotherapy: 25 Gy in 5 daily fractions over 1 week (short-course, distinct from long-course 50.4 Gy). Given before systemic therapy in both arms.
FruquintinibDrug
Oral VEGFR-1/2/3 tyrosine kinase inhibitor, ~5 mg once daily, started after radiotherapy with tislelizumab + CAPOX. Investigational addition in the experimental arm only.
TislelizumabDrug
IV anti-PD-1 monoclonal antibody, 200 mg every 3 weeks, given after radiotherapy with CAPOX ± fruquintinib per arm.
CAPOXDrug
Oxaliplatin ~130 mg/m2 IV on day 1 + capecitabine ~1000 mg/m2 orally twice daily on days 1-14, every 3 weeks, after radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Short-Course Radiotherapy followed by Fruquintinib, Tislelizumab, and CAPOX | Experimental | Not described Receives: Radiation: Short-Course Radiotherapy; Drug: Fruquintinib; Drug: Tislelizumab; Drug: CAPOX |
| Short-Course Radiotherapy followed by Tislelizumab, and CAPOX | Active comparator | Not described Receives: Radiation: Short-Course Radiotherapy; Drug: Tislelizumab; Drug: CAPOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving pathological complete response (pCR; ypT0N0)
pCR is defined as the absence of any viable tumor cells in the primary tumor bed and regional lymph nodes (ypT0N0) in the surgical resection specimen, per AJCC 8th edition TNM and College of American Pathologists (CAP) protocols, determined by blinded central pathology review. Assessed on the total mesorectal excision (TME) specimen after completion of neoadjuvant therapy. Reported as the number and percentage of randomized participants achieving ypT0N0, with 95% confidence intervals (intention-to-treat).
Measured: At response restaging (rectal MRI, colonoscopy, and MRD) and surgical resection, approximately 11-12 weeks after enrollment
Secondary outcomes (8)
3 years EFS
Measured: From enrollment to the time (3 years)
Overall Survival
Time from randomization to death from any cause, estimated by Kaplan-Meier method; reported as median OS with 95% confidence interval and the 5-year OS rate.
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
R0 resection rate
Measured: From randomization to surgical resection (approximately 4-6 months)
Objective Response Rate
Measured: At restaging tumor assessment (rectal MRI) after completion of neoadjuvant therapy, approximately 11-12 weeks after enrollment, prior to surgery
Minimal Residual Disease (MRD) status
Measured: At restaging tumor assessment (rectal MRI) after completion of neoadjuvant therapy, approximately 11-12 weeks after enrollment, prior to surgery
Proportion of participants achieving organ preservation via Watch-and-Wait (W&W) without definitive surgery
Among participants with clinical complete response (cCR; negative rectal MRI, colonoscopy, and MRD) at restaging approximately 11-12 weeks after enrollment, proportion who entered W\&W and avoided definitive total mesorectal excision/proctectomy through last follow-up. Reported as number and percentage with 95% confidence interval. Unit: proportion (%).
Measured: Through study completion, assessed up to 24 months after enrollment
Rate of local regrowth during Watch-and-Wait (W&W) surveillance
Among participants managed by W\&W, proportion who develop local regrowth (detected by rectal MRI and/or colonoscopy with biopsy confirmation) during surveillance. Reported as number and percentage with 95% CI. Unit: proportion (%).
Measured: Through study completion, assessed up to 24 months after enrollment
Relapse-free survival (RFS) in Watch-and-Wait (W&W) participants
Time from randomization to local regrowth, distant metastasis, or death from any cause, whichever came first, estimated by Kaplan-Meier; reported as median RFS with 95% CI. Unit: time (months).
Measured: From date of randomization until local regrowth, distant metastasis, or death from any cause, whichever came first, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start11 Sep 2025
- Primary completion11 Sep 2027 (estimated)
- Study completion11 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei Xue, Principal investigator, Shanghai Jiaotong University School of Medicine Affiliated Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888309
- Sponsor's protocol ID
- 2026407
- Acronym
- TRIP-FAST
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned for public sharing. Access to de-identified data may be granted upon reasonable request to the corresponding author, subject to an approved data-sharing agreement and independent ethics committee approval, for the purpose of verifying the study results.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Course Radiotherapy Followed by Fruquintinib Plus Tislelizumab and CAPOX Versus Short-Course Radiotherapy Followed by Tislelizumab and CAPOX for Neoadjuvant Treatment of Locally Advanced Low Rectal Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07888309
- Acronym / sponsor ID
- TRIP-FAST / 2026407
- Conditions
- Rectal Neoplasms, Rectal Cancer, Adenocarcinoma
- Keywords
- Short-course radiotherapy, Fruquintinib, Tislelizumab, CAPOX, Neoadjuvant therapy, Locally advanced low rectal cancer, Pathological complete response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 11 Sep 2027 (estimated)
- Study completion
- 11 Sep 2030 (estimated)
- First posted
- 22 Oct 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.
The goal of this randomized controlled clinical trial is to learn if adding fruquintinib to short-course radiotherapy, tislelizumab, and CAPOX can improve neoadjuvant treatment response and is safe for adults with locally advanced low rectal cancer. The main questions it aims to answer are:
- Does adding fruquintinib increase the pathological complete response (pCR) rate after neoadjuvant therapy?
- What adverse events do participants experience when fruquintinib is added to the regimen? Researchers will compare short-course radiotherapy followed by fruquintinib + tislelizumab + CAPOX with short-course radiotherapy followed by tislelizumab + CAPOX to see if adding fruquintinib improves the tumor response to neoadjuvant treatment.
Participants will:
- Receive short-course radiotherapy (e.g., 25 Gy in 5 daily fractions over 1 week)
- Receive either fruquintinib + tislelizumab + CAPOX (experimental arm) or tislelizumab + CAPOX (control arm) for the neoadjuvant cycles
- Attend scheduled visits for tumor assessment (MRI, endoscopy, CT), blood tests, and adverse-event monitoring
- Undergo total mesorectal excision (TME) surgery after neoadjuvant treatment and have the specimen evaluated for pathological response
Detailed description
Background Locally advanced rectal cancer is cancer of the rectum that has grown deeply into the bowel wall or into nearby tissues or lymph nodes, but has not yet spread to distant organs. When the tumor sits in the lower part of the rectum, the standard operation to remove it can put the muscles that control bowel continence at risk, sometimes requiring a permanent colostomy (a surgical opening of the intestine to the abdominal wall). To reduce this risk, doctors often give treatment before surgery - called neoadjuvant (preoperative) therapy - with the goal of shrinking the tumor, increasing the chance that no cancer remains, and preserving the patient's natural bowel function.
Current neoadjuvant approaches A widely used strategy is short-course radiotherapy (a brief, intensified course of pelvic radiation) followed by chemotherapy, and increasingly by immunotherapy. Radiotherapy and chemotherapy kill cancer cells directly, while immunotherapy helps the patient's own immune system recognize and attack the tumor. Combining all three - radiation, immune-based therapy, and chemotherapy - is an active and promising direction in rectal cancer care.
Why this study is being done Not every patient's tumor responds completely to existing neoadjuvant treatment, and some still require extensive surgery or a permanent stoma. This study tests whether adding a drug called fruquintinib - which starves the tumor by blocking VEGF receptors that fuel its blood supply - to the combination of short-course radiotherapy, the immunotherapy tislelizumab, and the chemotherapy CAPOX, can improve the likelihood that no living cancer cells remain in the tissue removed at surgery. Cutting off a tumor's blood supply may also make immunotherapy and chemotherapy work more effectively.
What participating means People who join this randomized trial are assigned by chance to one of two treatment plans. Both groups receive the same short-course radiotherapy followed by tislelizumab and CAPOX chemotherapy; the experimental group additionally receives fruquintinib. Treatment is given before surgery. After the neoadjuvant phase, standard rectal cancer surgery is performed and the removed specimen is examined for how much cancer remains. Throughout the study, participants have regular imaging, endoscopy, and blood-test assessments and are closely monitored for side effects.
Study aims The central question is whether adding fruquintinib increases the rate of pathological complete response - meaning the surgical specimen shows no remaining viable tumor - and whether the added drug is tolerable. A higher complete-response rate could mean more patients are able to keep their bowel function and avoid a permanent stoma.
Why it matters If the experimental combination proves more effective and acceptable, it could offer a new neoadjuvant option for people with locally advanced low rectal cancer who hope to preserve bowel function. The results will also help show whether blocking a tumor's blood supply alongside immune-based and chemical treatment is a useful strategy in this disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-Course Radiotherapy followed by Fruquintinib, Tislelizumab, and CAPOX | Experimental | Radiation: Short-Course Radiotherapy, Drug: Fruquintinib, Drug: Tislelizumab, Drug: CAPOX |
| Short-Course Radiotherapy followed by Tislelizumab, and CAPOX | Active comparator | Radiation: Short-Course Radiotherapy, Drug: Tislelizumab, Drug: CAPOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Has voluntarily signed a written informed consent form before any study-specific procedures.
- Age 18 to 75 years (inclusive), with no restriction on sex.
- Histologically confirmed locally advanced rectal adenocarcinoma by biopsy.
- Pelvic MRI shows high-risk features, meeting any one of the following:
- The inferior margin of the tumor is ≤ 10 cm from the anal verge.
Key exclusion criteria (19 listed)
- History of allergy to any anti-angiogenic targeted drug, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-containing agents.
- Has received or is receiving any of the following treatments:
- Any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for enrollment after hormone replacement therapy); subjects with psoriasis or childhood asthma/allergy that has completely resolved and requires no intervention after adulthood may be considered for enrollment, but those requiring bronchodilator medical intervention are excluded.
- History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.
- Uncontrolled cardiac clinical symptoms or diseases, including but not limited to: (1) heart failure of NYHA class II or higher, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia that remains uncontrolled with or without clinical intervention, (5) hypertension not well controlled by a single antihypertensive agent (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg) or requiring two or more antihypertensive agents, (6) New York Heart Association (NYHA) cardiac function class > II or left ventricular ejection fraction (LVEF) < 50%.
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 RadiotherapyPreoperative pelvic external-beam radiotherapy: 25 Gy in 5 daily fractions over 1 week (short-course, distinct from long-course 50.4 Gy). Given before systemic therapy in both arms. | Radiation | Short-Course Radiotherapy followed by Fruquintinib, Tislelizumab, and CAPOX, Short-Course Radiotherapy followed by Tislelizumab, and CAPOX |
| FruquintinibOral VEGFR-1/2/3 tyrosine kinase inhibitor, ~5 mg once daily, started after radiotherapy with tislelizumab + CAPOX. Investigational addition in the experimental arm only. | Drug | Short-Course Radiotherapy followed by Fruquintinib, Tislelizumab, and CAPOX |
| TislelizumabIV anti-PD-1 monoclonal antibody, 200 mg every 3 weeks, given after radiotherapy with CAPOX ± fruquintinib per arm. | Drug | Short-Course Radiotherapy followed by Fruquintinib, Tislelizumab, and CAPOX, Short-Course Radiotherapy followed by Tislelizumab, and CAPOX |
| CAPOXOxaliplatin ~130 mg/m2 IV on day 1 + capecitabine ~1000 mg/m2 orally twice daily on days 1-14, every 3 weeks, after radiotherapy | Drug | Short-Course Radiotherapy followed by Fruquintinib, Tislelizumab, and CAPOX, Short-Course Radiotherapy followed by Tislelizumab, and CAPOX |
Primary outcome
Proportion of participants achieving pathological complete response (pCR; ypT0N0)
Time frame: At response restaging (rectal MRI, colonoscopy, and MRD) and surgical resection, approximately 11-12 weeks after enrollment
pCR is defined as the absence of any viable tumor cells in the primary tumor bed and regional lymph nodes (ypT0N0) in the surgical resection specimen, per AJCC 8th edition TNM and College of American Pathologists (CAP) protocols, determined by blinded central pathology review. Assessed on the total mesorectal excision (TME) specimen after completion of neoadjuvant therapy. Reported as the number and percentage of randomized participants achieving ypT0N0, with 95% confidence intervals (intention-to-treat).
8 secondary outcomes
3 years EFS
Time frame: From enrollment to the time (3 years)
Overall Survival
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
R0 resection rate
Time frame: From randomization to surgical resection (approximately 4-6 months)
Objective Response Rate
Time frame: At restaging tumor assessment (rectal MRI) after completion of neoadjuvant therapy, approximately 11-12 weeks after enrollment, prior to surgery
Minimal Residual Disease (MRD) status
Time frame: At restaging tumor assessment (rectal MRI) after completion of neoadjuvant therapy, approximately 11-12 weeks after enrollment, prior to surgery
Proportion of participants achieving organ preservation via Watch-and-Wait (W&W) without definitive surgery
Time frame: Through study completion, assessed up to 24 months after enrollment
Rate of local regrowth during Watch-and-Wait (W&W) surveillance
Time frame: Through study completion, assessed up to 24 months after enrollment
Relapse-free survival (RFS) in Watch-and-Wait (W&W) participants
Time frame: From date of randomization until local regrowth, distant metastasis, or death from any cause, whichever came first, assessed up to 36 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 22 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned for public sharing. Access to de-identified data may be granted upon reasonable request to the corresponding author, subject to an approved data-sharing agreement and independent ethics committee approval, for the purpose of verifying the study results.
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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.
Pei Xue principal investigator
Shanghai Jiaotong University School of Medicine Affiliated Ruijin Hospital
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, Fruquintinib and Tislelizumab in people with Rectal Neoplasms and Rectal Cancer, Adenocarcinoma, 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 21 inclusion and 19 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pei Xue (86-21-64370045, xuepei0415@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving pathological complete response (pCR; ypT0N0) (time frame: At response restaging (rectal MRI, colonoscopy, and MRD) and surgical resection, approximately 11-12 weeks after enrollment). 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 22 Oct 2026.