Rectal CancerPhase 2RADIANTNCT07774754
Radiotherapy Combined With Capeox Chemotherapy, Sintilimab and Suvemcitug in Locally Advanced pMMR Rectal Cancer:a Prospective Clinical Trial
A Phase 2 study testing Drug：sintilimab, Drug：Capecitabine and Drug：Suvemcitug in people with Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study is a prospective, single-arm clinical trial with a dose-reduction design, which is expected to enrol 18 patients with locally advanced rectal cancer with pMMR status. The aim is to investigate the safety and efficacy of neoadjuvant chemoradiotherapy combined with sintilimab and suvecitib. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Drug：sintilimab, Drug：Capecitabine and Drug：Suvemcitug
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Sep 2031
- 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
- 1) Aged 18-75 years;
- 2) ECOG 0-1;
- 3) Histologically confirmed rectal adenocarcinoma;
- 4) Preoperative staging: cT3-4N0M0 or cT1-4N+M0;
- 5) Distance from the tumour's inferior margin to the anus ≤ 12 cm;
- 6) Tumour biopsy immunohistochemistry indicates pMMR, i.e. positive expression of all MSH1/MSH2/MSH6/PMS2, and molecular testing indicates MSS (microsatellite-stable).
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- 7) Haematological parameters: WBC > 4,000/mm³; PLT > 100,000/mm³; Hb should, in principle, be > 10 g/dL; chronic anaemia (haemoglobin < 10.0 g/dL) is not an exclusion criterion and may be assessed by a multidisciplinary team;
- 8) Liver function: Serum total bilirubin ≤ 1.5 × ULN (for subjects with Gilbert's syndrome, total bilirubin ≤ 3 × ULN is allowed)；aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN；
- 9) Renal function: serum creatinine ≤ 1.5 × ULN, or creatinine clearance > 50 mL/min;
- 10) Other: not pregnant or breastfeeding; no other malignant diseases within the past 5 years or concurrently (excluding basal cell carcinoma of the skin or cervical carcinoma in situ); no mental illness preventing the provision of informed consent; no concomitant serious diseases that would shorten survival;
- 11) No previous surgery, chemotherapy or radiotherapy for rectal cancer;
- 12) No previous immunotherapy;
- 13) Previous endocrine therapy: no restrictions.
Who cannot join
- 1) Failure to sign an informed consent form;
- 2) Immunohistochemistry of tumor biopsy specimens indicating dMMR or microsatellite instability testing indicating MSI-H;
- 3) Preoperative evidence of distant metastasis;
- 4) History of severe bleeding tendency or coagulation disorders; patients who have previously or currently require long-term anticoagulant therapy (e.g., patients with atrial fibrillation who have a CHADS2 score of ≥2).
- 5) History of myocarditis, cardiomyopathy, or malignant arrhythmias. History of unstable angina, congestive heart failure, or vascular disease (e.g., an aortic aneurysm requiring surgical repair or peripheral venous thrombosis) requiring hospitalization within 12 months prior to study treatment, or other cardiac conditions that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial infarction, or ischemia) ;
- 6) History of esophageal or fundic varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to study treatment;
Show all 18Show fewer
- 7) History of any arterial thromboembolic event, venous thromboembolism of Grade 3 or higher according to NCI CTCAE Version 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to study treatment;
- 8)An acute exacerbation of chronic obstructive pulmonary disease (COPD) within 1 month prior to study treatment; current hypertension with a systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite treatment with oral antihypertensive medications; severe hypertension that is poorly controlled with medication;
- 9) History of HIV infection or active chronic hepatitis B or C, or other active, clinically significant infections;
- 10) Subjects with active pulmonary tuberculosis (TB) who are currently receiving antituberculosis therapy or who have received such therapy within 1 year prior to screening;
- 11) Cachexia, organ dysfunction;
- 12) History of pelvic or abdominal radiation therapy;
- 13) Multiple primary colorectal cancers;
- 14) Patients with seizures requiring treatment (e.g., with steroids or antiepileptic therapy);
- 15) History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ or basal cell carcinoma of the skin;
- 16) Substance abuse, or medical, psychological, or social conditions that may interfere with the patient's participation in the study or affect the evaluation of study results;
- 17) Known or suspected allergy to the study drug or to any medication administered in connection with this trial;
- 18) Any unstable condition or situation that may jeopardize the patient's safety or compliance;Pregnant or breastfeeding women of childbearing potential who are not using adequate contraception.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study is a prospective, single-arm clinical trial with a dose-reduction design, which is expected to enrol 18 patients with locally advanced rectal cancer with pMMR status. The aim is to investigate the safety and efficacy of neoadjuvant chemoradiotherapy combined with sintilimab and suvecitib.
Patients will receive long-course chemoradiotherapy (concurrent capecitabine, 1000 mg/m², twice daily, days 1-14, Q3W, 2 cycles; sintilimab, 200 mg, d1, IV drip, Q3W, 2 cycles), followed by 6 cycles of the Capeox regimen in combination with sintilimab and suvecitib, namely oxaliplatin 130 mg/m², d1, IV infusion, every 3 weeks; and capecitabine 1,000 mg/m², twice daily, days 1-14, every 3 weeks; sintilimab, 200 mg, Day 1, IV drip, every 3 weeks; suvectitumab (anti-angiogenic agent), 2.0/1.5/1.0 mg/kg, Day 1, IV drip, every 3 weeks. A total of 8 cycles of sintilimab and 6 cycles of suvectitumab were administered during the neoadjuvant treatment period.
If, following completion of neoadjuvant therapy, the subject has not achieved cCR/near-cCR status, TME surgery or other therapeutic surgery shall be performed; the interval between the final dose of suvectitumab and surgery should be ≥6 weeks. If cCR/near-cCR status is achieved, watchful waiting or other treatment options shall be discussed with the patient. The adjuvant treatment regimen following surgery shall be determined by the investigator based on the patient's pathological results.
Read the detailed description
This study is a prospective, single-arm clinical trial with a dose-reduction design, which is expected to enrol 18 patients with locally advanced rectal cancer with pMMR status. The aim is to investigate the safety and efficacy of neoadjuvant chemoradiotherapy combined with sintilimab and suvecitib.
Patients will receive long-course chemoradiotherapy (concurrent capecitabine, 1000 mg/m², twice daily, days 1-14, Q3W, 2 cycles; sintilimab, 200 mg, d1, IV drip, Q3W, 2 cycles), followed by 6 cycles of the Capeox regimen in combination with sintilimab and suvecitib, namely oxaliplatin 130 mg/m², d1, IV infusion, every 3 weeks; and capecitabine 1,000 mg/m², twice daily, days 1-14, every 3 weeks; sintilimab, 200 mg, Day 1, IV drip, every 3 weeks; suvectitumab (anti-angiogenic agent), 2.0/1.5/1.0 mg/kg, Day 1, IV drip, every 3 weeks. A total of 8 cycles of sintilimab and 6 cycles of suvectitumab were administered during the neoadjuvant treatment period.
According to data from previous studies, the recommended dose of suvecitib in combination with a PD-L1 inhibitor and FOLFIRI chemotherapy for second-line treatment of advanced MSS colorectal cancer is 2 mg/kg every 2 weeks. However, given that the neoadjuvant treatment regimen in this clinical trial involves multiple modalities-including chemotherapy, radiotherapy, targeted therapy and immunotherapy-and the intensity is high with unknown toxicity profiles, a dose-escalation design was adopted in the early phase of this clinical study.
Specifically, six patients will initially be enrolled to receive suvicitabant at 2 mg/kg to assess safety. Following completion of neoadjuvant therapy in the third patient, if two or more patients develop Grade 4 acute radiation-induced rectal injury, the dose of suvicitabant will be reduced to 1.5 mg/kg for re-evaluation. If two or more patients still develop Grade 4 acute radiation-induced rectal injury, the dose will be further reduced to 1 mg/kg for re-evaluation.
If 1 or fewer patients develop Grade 4 acute radiation-induced rectal injury, the sample size for this cohort will be expanded to 18 patients. Following completion of neoadjuvant therapy, if a subject has not achieved cCR/near-cCR status, they will undergo TME or other therapeutic surgery; the interval between the final dose of suvecitib and surgery must be ≥6 weeks. If cCR/near-cCR status is achieved, watchful waiting or other treatment options will be discussed with the patient. Postoperatively, the investigator shall determine the adjuvant treatment regimen based on the patient's pathological results.
- Conditions
- Rectal Cancer
- Being tested
- Drug：sintilimab, Drug：Capecitabine, Drug：Suvemcitug, Radiation: Neoadjuvant Radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug：sintilimabDrug
During neo-CRT: 2 cycles of sintilimab, 200mg d1 q3w. After neo-CRT: 6 cycles of sintilimab, 200mg d1 q3w.
Drug：CapecitabineDrug
During neo-CRT: capecitabine, 1000 mg/m², twice daily, days 1-14, every 3 weeks, 2 cycles. After neo-CRT: 6 cycles of capecitabine, 1000 mg/m², twice daily, days 1-14, every 3 weeks.
Drug：SuvemcitugDrug
After neo-CRT: 6 cycles of suvecitib (anti-angiogenic agent), 2.0/1.5/1.0 mg/kg, Day 1, every 3 weeks.
Radiation: Neoadjuvant RadiotherapyRadiation
IMRT DT: 50Gy/25Fx
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | This study is expected to enroll 18 patients with pMMR locally advanced rectal cancer. Patients will receive long-term chemoradiotherapy (concurrent capecitabine and two cycles of sintilimab), followed by six cycles of the Capeox regimen in combination with sintilimab and Suvemcitug.
Initially, 6 patients will be enrolled to receive 2 mg/kg of suvecitib for safety evaluation. After the third patient completes neoadjuvant therapy, if two or more patients develop Grade 4 acute radiation-induced rectal injury, the dose of suvecitib will be reduced to 1.5 mg/kg for re-evaluation. If two or more patients still develop Grade 4 acute radiation-induced rectal injury, the dose will be further reduced to 1 mg/kg for re-evaluation.If 1 or fewer patients develop Grade 4 acute radiation-induced rectal injury, the sample size for this cohort will be expanded to 18 patients. Receives: Drug: Drug：sintilimab; Drug: Drug：Capecitabine; Drug: Drug：Suvemcitug; Radiation: Radiation: Neoadjuvant Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Effects of Neoadjuvant Therapy
Measured: During neoadjuvant therapy
Secondary outcomes (9)
Complete response (CR) rate
Rate of complete response (CR), including pathologic complete response (pCR) and clinical complete response (cCR).
Measured: The proportion of participants who achieved either of the following outcomes following neoadjuvant therapy: pathological complete response (pCR) or clinical complete response (cCR)
major pathological response and tumor regression grade
Measured: At the time of surgical pathological assessment
R0 rate
Measured: At the time of surgical pathological assessment
Long-Term Quality of Life
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores will be linearly transformed to a 0-100 scale. For the global health status/quality-of-life scale, a higher score represents a better level of global health status and quality of life. Changes from baseline will be evaluated during follow-up.
Measured: From date of randomization , assessed up to 60 months.
Incidence of Surgical Complications
Measured: the surgical complications were assessed up to 1 year from the surgery.
Distant Metastasis Rate
Measured: within 3 years of randomization
Local recurrence rate
Measured: within 3 years of randomization
5-Year Overall Survival Rate
Measured: The time from randomization to death from any cause,assessed up to 60 months.
3-Year Event-Free Survival Rate
Measured: 3 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WeiWei Xiao, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774754
- Sponsor's protocol ID
- B2026-381-01
- Acronym
- RADIANT
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy Combined With Capeox Chemotherapy, Sintilimab and Suvemcitug in Locally Advanced pMMR Rectal Cancer:a Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT07774754
- Acronym / sponsor ID
- RADIANT / B2026-381-01
- Conditions
- Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 19 Aug 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 is a prospective, single-arm clinical trial with a dose-reduction design, which is expected to enrol 18 patients with locally advanced rectal cancer with pMMR status. The aim is to investigate the safety and efficacy of neoadjuvant chemoradiotherapy combined with sintilimab and suvecitib.
Patients will receive long-course chemoradiotherapy (concurrent capecitabine, 1000 mg/m², twice daily, days 1-14, Q3W, 2 cycles; sintilimab, 200 mg, d1, IV drip, Q3W, 2 cycles), followed by 6 cycles of the Capeox regimen in combination with sintilimab and suvecitib, namely oxaliplatin 130 mg/m², d1, IV infusion, every 3 weeks; and capecitabine 1,000 mg/m², twice daily, days 1-14, every 3 weeks; sintilimab, 200 mg, Day 1, IV drip, every 3 weeks; suvectitumab (anti-angiogenic agent), 2.0/1.5/1.0 mg/kg, Day 1, IV drip, every 3 weeks. A total of 8 cycles of sintilimab and 6 cycles of suvectitumab were administered during the neoadjuvant treatment period.
If, following completion of neoadjuvant therapy, the subject has not achieved cCR/near-cCR status, TME surgery or other therapeutic surgery shall be performed; the interval between the final dose of suvectitumab and surgery should be ≥6 weeks. If cCR/near-cCR status is achieved, watchful waiting or other treatment options shall be discussed with the patient. The adjuvant treatment regimen following surgery shall be determined by the investigator based on the patient's pathological results.
Detailed description
This study is a prospective, single-arm clinical trial with a dose-reduction design, which is expected to enrol 18 patients with locally advanced rectal cancer with pMMR status. The aim is to investigate the safety and efficacy of neoadjuvant chemoradiotherapy combined with sintilimab and suvecitib.
Patients will receive long-course chemoradiotherapy (concurrent capecitabine, 1000 mg/m², twice daily, days 1-14, Q3W, 2 cycles; sintilimab, 200 mg, d1, IV drip, Q3W, 2 cycles), followed by 6 cycles of the Capeox regimen in combination with sintilimab and suvecitib, namely oxaliplatin 130 mg/m², d1, IV infusion, every 3 weeks; and capecitabine 1,000 mg/m², twice daily, days 1-14, every 3 weeks; sintilimab, 200 mg, Day 1, IV drip, every 3 weeks; suvectitumab (anti-angiogenic agent), 2.0/1.5/1.0 mg/kg, Day 1, IV drip, every 3 weeks. A total of 8 cycles of sintilimab and 6 cycles of suvectitumab were administered during the neoadjuvant treatment period.
According to data from previous studies, the recommended dose of suvecitib in combination with a PD-L1 inhibitor and FOLFIRI chemotherapy for second-line treatment of advanced MSS colorectal cancer is 2 mg/kg every 2 weeks. However, given that the neoadjuvant treatment regimen in this clinical trial involves multiple modalities-including chemotherapy, radiotherapy, targeted therapy and immunotherapy-and the intensity is high with unknown toxicity profiles, a dose-escalation design was adopted in the early phase of this clinical study.
Specifically, six patients will initially be enrolled to receive suvicitabant at 2 mg/kg to assess safety. Following completion of neoadjuvant therapy in the third patient, if two or more patients develop Grade 4 acute radiation-induced rectal injury, the dose of suvicitabant will be reduced to 1.5 mg/kg for re-evaluation. If two or more patients still develop Grade 4 acute radiation-induced rectal injury, the dose will be further reduced to 1 mg/kg for re-evaluation.
If 1 or fewer patients develop Grade 4 acute radiation-induced rectal injury, the sample size for this cohort will be expanded to 18 patients. Following completion of neoadjuvant therapy, if a subject has not achieved cCR/near-cCR status, they will undergo TME or other therapeutic surgery; the interval between the final dose of suvecitib and surgery must be ≥6 weeks. If cCR/near-cCR status is achieved, watchful waiting or other treatment options will be discussed with the patient. Postoperatively, the investigator shall determine the adjuvant treatment regimen based on the patient's pathological results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Drug：sintilimab, Drug: Drug：Capecitabine, Drug: Drug：Suvemcitug, Radiation: Radiation: Neoadjuvant RadiotherapyThis study is expected to enroll 18 patients with pMMR locally advanced rectal cancer. Patients will receive long-term chemoradiotherapy (concurrent capecitabine and two cycles of sintilimab), followed by six cycles of the Capeox regimen in combination with sintilimab and Suvemcitug. Initially, 6 patients will be enrolled to receive 2 mg/kg of suvecitib for safety evaluation. After the third patient completes neoadjuvant therapy, if two or more patients develop Grade 4 acute radiation-induced rectal injury, the dose of suvecitib will be reduced to 1.5 mg/kg for re-evaluation. If two or more patients still develop Grade 4 acute radiation-induced rectal injury, the dose will be further reduced to 1 mg/kg for re-evaluation.If 1 or fewer patients develop Grade 4 acute radiation-induced rectal injury, the sample size for this cohort will be expanded to 18 patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1) Aged 18-75 years;
- 2) ECOG 0-1;
- 3) Histologically confirmed rectal adenocarcinoma;
- 4) Preoperative staging: cT3-4N0M0 or cT1-4N+M0;
- 5) Distance from the tumour's inferior margin to the anus ≤ 12 cm;
Key exclusion criteria (18 listed)
- 1) Failure to sign an informed consent form;
- 2) Immunohistochemistry of tumor biopsy specimens indicating dMMR or microsatellite instability testing indicating MSI-H;
- 3) Preoperative evidence of distant metastasis;
- 4) History of severe bleeding tendency or coagulation disorders; patients who have previously or currently require long-term anticoagulant therapy (e.g., patients with atrial fibrillation who have a CHADS2 score of ≥2).
- 5) History of myocarditis, cardiomyopathy, or malignant arrhythmias. History of unstable angina, congestive heart failure, or vascular disease (e.g., an aortic aneurysm requiring surgical repair or peripheral venous thrombosis) requiring hospitalization within 12 months prior to study treatment, or other cardiac conditions that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial infarction, or ischemia) ;
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 |
|---|---|---|
| Drug：sintilimabDuring neo-CRT: 2 cycles of sintilimab, 200mg d1 q3w. After neo-CRT: 6 cycles of sintilimab, 200mg d1 q3w. | Drug | Treatment Arm |
| Drug：CapecitabineDuring neo-CRT: capecitabine, 1000 mg/m², twice daily, days 1-14, every 3 weeks, 2 cycles. After neo-CRT: 6 cycles of capecitabine, 1000 mg/m², twice daily, days 1-14, every 3 weeks. | Drug | Treatment Arm |
| Drug：SuvemcitugAfter neo-CRT: 6 cycles of suvecitib (anti-angiogenic agent), 2.0/1.5/1.0 mg/kg, Day 1, every 3 weeks. | Drug | Treatment Arm |
| Radiation: Neoadjuvant RadiotherapyIMRT DT: 50Gy/25Fx | Radiation | Treatment Arm |
Primary outcome
Serious Adverse Effects of Neoadjuvant Therapy
Time frame: During neoadjuvant therapy
9 secondary outcomes
Complete response (CR) rate
Time frame: The proportion of participants who achieved either of the following outcomes following neoadjuvant therapy: pathological complete response (pCR) or clinical complete response (cCR)
major pathological response and tumor regression grade
Time frame: At the time of surgical pathological assessment
R0 rate
Time frame: At the time of surgical pathological assessment
Long-Term Quality of Life
Time frame: From date of randomization , assessed up to 60 months.
Incidence of Surgical Complications
Time frame: the surgical complications were assessed up to 1 year from the surgery.
Distant Metastasis Rate
Time frame: within 3 years of randomization
Local recurrence rate
Time frame: within 3 years of randomization
5-Year Overall Survival Rate
Time frame: The time from randomization to death from any cause,assessed up to 60 months.
3-Year Event-Free Survival Rate
Time frame: 3 years after randomization
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 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Drug：sintilimab, Drug：Capecitabine and Drug：Suvemcitug in people with Rectal Cancer, run by Sun Yat-sen 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 13 inclusion and 18 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: opening soon, as of the sponsor's last update on 19 Aug 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 Xiao weiwei (8613710390520, xiaoww@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Effects of Neoadjuvant Therapy (time frame: During neoadjuvant therapy). 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 19 Aug 2026.