Locally Advanced Rectal CancerPhase 3NCT07917468
Sintilimab Combined With LCCRT Followed by Capeox Chemotherapy in pMMR/MSS/MSI-L Locally Advanced Rectal Cancer
A Phase 3 study testing Oxaliplatin, radiotherapy and Capecitabine in people with Locally Advanced Rectal Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, controlled, Phase III clinical study to evaluate the efficacy and safety of sintilimab combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy, which is planned to enroll 500 subjects with locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Oxaliplatin, radiotherapy and Capecitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2026to 24 Nov 2031
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has signed the written Informed Consent Form and is capable of complying with the visit schedules and relevant procedures specified in the protocol.
- Histopathologically confirmed locally advanced rectal adenocarcinoma, with clinical stage cT3-4NanyM0 or cT1-2N1-2M0 as defined by the AJCC 8th edition, and assessed as amenable to R0 resection after neoadjuvant therapy. MRI demonstrates that the lower edge of the tumor is within 10 cm from the anal verge.
- Tumor pathological tissue testing confirms pMMR, i.e., immunohistochemical staining shows positive expression of all four proteins MLH1, MSH2, MSH6, and PMS2, or tumor tissue-based genetic testing indicates MSI-L or MSS.
- No signs of intestinal obstruction; or intestinal obstruction that has been relieved after proximal colostomy.
- No prior rectal surgery; no prior systemic anti-cancer therapy, or other investigational drug therapy.
- Age ≥18 years, both sexes eligible.
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- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Expected survival of ≥2 years.
- Adequate bone marrow and organ function. Exclusion Criteria
- 1. Currently participating in another interventional clinical study, except for observational (non-interventional) clinical studies or those in the survival follow-up phase of an interventional study.
- 2. Plans to receive other anti-tumor therapy during the treatment period of this study.
- 3. Receipt of any live vaccine within 4 weeks before the first dose of study drug, or plans to receive any live vaccine during the study period.
- 4. Presence of toxicity from prior therapy that has not recovered to Grade 0 or 1 per NCI CTCAE V6.0 before the first dose of study drug (excluding alopecia, fatigue, pigmentation, and other conditions judged by the investigator to pose no safety risk).
- 5. Major surgery 6. Receipt of immunosuppressive therapy within 4 weeks before the first dose of study drug, excluding topical corticosteroids administered intranasally, by inhalation, or by other local routes, or physiological doses of systemic corticosteroids , or corticosteroids used to prevent contrast agent allergy.
- 7. Recurrent rectal cancer; multiple primary colorectal cancers. 8. History of pelvic or abdominal radiotherapy.
Who cannot join
None listed.
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
Sun Yat sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu, +86-20-87343468, xurh2@sysucc.org.cn
About this study
Official title: Sintilimab Combined With Long-Course Concurrent Chemoradiotherapy Followed by Capeox Consolidation Chemotherapy vs. Long-Course Concurrent Chemoradiotherapy Followed by Capeox Consolidation Chemotherapy for Total Neoadjuvant Therapy in Patients With Mismatch Repair-Proficient (pMMR) or Microsatellite Stable/Low Microsatellite Instability (MSS/MSI-L) Locally Advanced Rectal Cancer: A Multicenter, Randomized, Double-Blind, Controlled Phase III Study
This is a randomized, double-blind, controlled, Phase III clinical study to evaluate the efficacy and safety of sintilimab combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy, which is planned to enroll 500 subjects with locally advanced rectal cancer.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Oxaliplatin, Placebo, radiotherapy, Capecitabine, Radical resection of rectal cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
130 mg/m²，IV，Q3W
PlaceboDrug
20 ml D1 IV Q3W
radiotherapyRadiation
PTV1 50 Gy/25 times, PTV2 45 Gy/25 times, 5 days a week, for a total of 5 weeks (D1-D35)
CapecitabineDrug
825 mg/m ² PO BID ,Days 1-5 QW；1000mg/m ² PO BID ,Days 1-14 Q3W；
Radical resection of rectal cancerProcedure or surgery
Radical resection of rectal cancer
SintilimabDrug
200 mg D1 IV Q3W
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy Receives: Drug: Oxaliplatin; Drug: Placebo; Radiation: radiotherapy; Drug: Capecitabine; Procedure: Radical resection of rectal cancer |
| Sintilimab | Experimental | sintilimab combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy Receives: Drug: Oxaliplatin; Radiation: radiotherapy; Drug: Capecitabine; Procedure: Radical resection of rectal cancer; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFS
EFS refers to the time from randomization to the first occurrence of any of the following events: disease progression precluding surgical treatment, local or distant recurrence, death from any cause, etc.
Measured: throutg treatment completion an average of 5 years
Secondary outcomes (7)
OS
OS is defined as the time from the date of randomization until the date of death from any cause.
Measured: throutg treatment completion an average of 5 years
CCR
CCR defined as the proportion of participants achieving pathological complete response (pCR) or clinical complete response (cCR)
Measured: up to 5 years after enrollment
R0 resection rate
R0 resection rate: Descriptive summary of R0 resection rate
Measured: up to 5 years after enrollment
EFS3
EFS3 defined as the proportion of participants who remain free from any of the following events for 3 years after randomization: disease progression precluding surgery, local or distant recurrence, or death from any cause
Measured: 3yaers
TRG
Pathological assessment of tumor regression grading (TRG) after neoadjuvant therapy
Measured: up to 5 years after enrollment
neoadjuvant therapy completion rate
Neoadjuvant therapy completion rate: Descriptive summary of Neoadjuvant therapy completion rate
Measured: up to 5 years after enrollment
OPR
The definition of organ preservation is: no radical total mesorectal excision (TME) performed, and no local regrowth, unless such regrowth can be salvaged by local excision achieving a limited, radical (R0) resection, with no permanent stoma (including a protective stoma that has never been reversed, or a stoma resulting from adverse events and/or poor functional outcome, or a permanent stoma).
Measured: up to 5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start25 Nov 2026 (estimated)
- Primary completion25 Mar 2030 (estimated)
- Study completion24 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917468
- Sponsor's protocol ID
- CIBI308H301
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab Combined With Long-Course Concurrent Chemoradiotherapy Followed by Capeox Consolidation Chemotherapy vs. Long-Course Concurrent Chemoradiotherapy Followed by Capeox Consolidation Chemotherapy for Total Neoadjuvant Therapy in Patients With Mismatch Repair-Proficient (pMMR) or Microsatellite Stable/Low Microsatellite Instability (MSS/MSI-L) Locally Advanced Rectal Cancer: A Multicenter, Randomized, Double-Blind, Controlled Phase III Study
- ClinicalTrials.gov ID
- NCT07917468
- Acronym / sponsor ID
- CIBI308H301
- Conditions
- Locally Advanced Rectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2026 (estimated)
- Primary completion
- 25 Mar 2030 (estimated)
- Study completion
- 24 Nov 2031 (estimated)
- First posted
- 4 Nov 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 is a randomized, double-blind, controlled, Phase III clinical study to evaluate the efficacy and safety of sintilimab combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy, which is planned to enroll 500 subjects with locally advanced rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Oxaliplatin, Drug: Placebo, Radiation: radiotherapy, Drug: Capecitabine, Procedure: Radical resection of rectal cancerPlacebo combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy |
| Sintilimab | Experimental | Drug: Oxaliplatin, Radiation: radiotherapy, Drug: Capecitabine, Procedure: Radical resection of rectal cancer, Drug: Sintilimabsintilimab combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Has signed the written Informed Consent Form and is capable of complying with the visit schedules and relevant procedures specified in the protocol.
- Histopathologically confirmed locally advanced rectal adenocarcinoma, with clinical stage cT3-4NanyM0 or cT1-2N1-2M0 as defined by the AJCC 8th edition, and assessed as amenable to R0 resection after neoadjuvant therapy. MRI demonstrates that the lower edge of the tumor is within 10 cm from the anal verge.
- Tumor pathological tissue testing confirms pMMR, i.e., immunohistochemical staining shows positive expression of all four proteins MLH1, MSH2, MSH6, and PMS2, or tumor tissue-based genetic testing indicates MSI-L or MSS.
- No signs of intestinal obstruction; or intestinal obstruction that has been relieved after proximal colostomy.
- No prior rectal surgery; no prior systemic anti-cancer therapy, or other investigational drug therapy.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Oxaliplatin130 mg/m²，IV，Q3W | Drug | Placebo, Sintilimab |
| Placebo20 ml D1 IV Q3W | Drug | Placebo |
| radiotherapyPTV1 50 Gy/25 times, PTV2 45 Gy/25 times, 5 days a week, for a total of 5 weeks (D1-D35) | Radiation | Placebo, Sintilimab |
| Capecitabine825 mg/m ² PO BID ,Days 1-5 QW；1000mg/m ² PO BID ,Days 1-14 Q3W； | Drug | Placebo, Sintilimab |
| Radical resection of rectal cancerRadical resection of rectal cancer | Procedure or surgery | Placebo, Sintilimab |
| Sintilimab200 mg D1 IV Q3W | Drug | Sintilimab |
Primary outcome
EFS
Time frame: throutg treatment completion an average of 5 years
EFS refers to the time from randomization to the first occurrence of any of the following events: disease progression precluding surgical treatment, local or distant recurrence, death from any cause, etc.
7 secondary outcomes
OS
Time frame: throutg treatment completion an average of 5 years
CCR
Time frame: up to 5 years after enrollment
R0 resection rate
Time frame: up to 5 years after enrollment
EFS3
Time frame: 3yaers
TRG
Time frame: up to 5 years after enrollment
neoadjuvant therapy completion rate
Time frame: up to 5 years after enrollment
OPR
Time frame: up to 5 years after enrollment
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 4 Nov 2026.
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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 3 study testing Oxaliplatin, radiotherapy and Capecitabine in people with Locally Advanced Rectal Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. 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 15 inclusion and 0 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 4 Nov 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yanxi Pu (+86-18523197816, yanxi.pu@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFS (time frame: throutg treatment completion an average of 5 years). 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 4 Nov 2026.