A Phase 3 interventional study of Oxaliplatin and Placebo in Locally Advanced Rectal Cancer, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Innovent Biologics (Suzhou) Co. Ltd. (part of Innovent Biologics, Inc.) · Phase 3, Interventional, and Treatment
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.
2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.
This study's planned enrollment of 500 is above the median of 65 across 1,751 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 199 studies on the registry; 46 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion 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 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 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 therapy within 4 weeks before the first dose of study drug, excluding topical 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy
Drug: Oxaliplatin · Drug: Placebo · Radiation: radiotherapy · Drug: Capecitabine · Procedure: Radical resection of rectal cancer
sintilimab combined with long-course concurrent chemoradiotherapy followed by Capeox consolidation chemotherapy
Drug: Oxaliplatin · Radiation: radiotherapy · Drug: Capecitabine · Procedure: Radical resection of rectal cancer · Drug: Sintilimab
130 mg/m²，IV，Q3W
20 ml D1 IV Q3W
PTV1 50 Gy/25 times, PTV2 45 Gy/25 times, 5 days a week, for a total of 5 weeks (D1-D35)
825 mg/m ² PO BID ,Days 1-5 QW；1000mg/m ² PO BID ,Days 1-14 Q3W；
Radical resection of rectal cancer
200 mg D1 IV Q3W
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.
Time frame: throutg treatment completion an average of 5 years
OS
OS is defined as the time from the date of randomization until the date of death from any cause.
Time frame: 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)
Time frame: up to 5 years after enrollment
R0 resection rate
R0 resection rate: Descriptive summary of R0 resection rate
Time frame: 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
Time frame: 3yaers
TRG
Pathological assessment of tumor regression grading (TRG) after neoadjuvant therapy
Time frame: up to 5 years after enrollment
neoadjuvant therapy completion rate
Neoadjuvant therapy completion rate: Descriptive summary of Neoadjuvant therapy completion rate
Time frame: 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).
Time frame: up to 5 years after enrollment
Start is estimated for Nov 2026; primary completion for Mar 2030, 40 months later.
Of 81 phase 3 interventional studies under Rectal Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 95. This study's planned 40 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sintilimab
Innovent Biologics (Suzhou) Co. Ltd. →