Rectal AdenocarcinomaPhase 3CRITⅡNCT07549399
SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC
A Phase 3 study testing Short-Course Radiotherapy, PD-1 monoclonal antibody and mFOLFOX6 regimen in people with Rectal Adenocarcinoma and High-Risk Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS/BRAF status: cetuximab for wild-type, bevacizumab for mutant) and a PD-1 monoclonal antibody, compared with short-course… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Adenocarcinoma, High-Risk Cancer, MSS
- What is being tested?
- Short-Course Radiotherapy, PD-1 monoclonal antibody and mFOLFOX6 regimen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 30 Apr 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulations and institutional guidelines.
- Age 18-75 years.
- Histologically or cytologically confirmed pMMR/MSS rectal adenocarcinoma; all other histological types are excluded.
- Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.
- Clinical staging with high-risk factors, including cT3Nx, EMVI(+), or cT4, ±MRF(+), ±EMVI(+).
- No evidence of distant metastasis before treatment.
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- No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).
- ECOG performance status of 0-1.
- Peripheral blood counts and liver and kidney function within the following allowable ranges (tested within 15 days before the start of treatment):
- White blood cells (WBC) ≥3.0×10^9/L or absolute neutrophil count (ANC) ≥1.5×10^9/L;
- Hemoglobin (HGB) ≥80 g/L; ③Platelets (PLT) ≥100×10^9/L; ④Liver transaminases (AST/ALT) <3.0 times the upper limit of the normal range; ⑤Total bilirubin (TBIL) <1.5 times the upper limit of the normal range; ⑥Creatinine (CREAT) <1.5 times the upper limit of the normal range.
- No history of other malignancies; not pregnant or breastfeeding, and effective contraception must be used during the study period and for 6 months after the last dose.
Who cannot join
- Patients with a history of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);
- Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;
- A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;
- Severe electrolyte abnormalities;
- Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or tumors with active bleeding that have not been resected; or other conditions that may lead to gastrointestinal bleeding or perforation; or gastrointestinal perforation that has not healed after surgical treatment;
- History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months; or patients receiving high-dose anticoagulation therapy;
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- Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants and their partners who are unwilling to strictly practice contraception during the study period;
- Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for more than 3 years, or in situ cancers that can be cured with adequate treatment);
- Presence of severe ECG abnormalities or active coronary artery disease, severe/unstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or New York Heart Association (NYHA) Class II or higher congestive heart failure;
- Patients with active infections (infections causing fever above 38°C);
- Patients with uncontrolled hypercalcemia, hypertension, or diabetes;
- Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);
- Patients with psychiatric disorders that may affect clinical treatment or a history of central nervous system diseases;
- Patients with severe complications (bowel obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);
- Presence of any CTCAE Grade 2 or higher toxicity caused by previous treatments that has not resolved (excluding anemia, alopecia, and skin pigmentation);
- Any unstable medical condition that may affect patient safety and compliance with the study;
- Patients deemed by the investigator as unsuitable for participation in this clinical trial.
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
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510065
Jun Hu, +86-020-38379764, zslyllb@mail.sysu.edu.cn
About this study
Official title: Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS/BRAF Wild-Type)/Bevacizumab (for RAS/BRAF Mutant) in High-Risk pMMR/MSS Rectal Adenocarcinoma: a Phase III Randomized Controlled Trial
To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS/BRAF status: cetuximab for wild-type, bevacizumab for mutant) and a PD-1 monoclonal antibody, compared with short-course radiotherapy followed by mFOLFOX6 chemotherapy alone, in high-risk locally advanced pMMR/MSS rectal adenocarcinoma through a prospective, randomized controlled phase III clinical study, providing high-level evidence-based medical evidence to establish a superior neoadjuvant treatment strategy for this population.
Read the detailed description
Patients with locally advanced rectal cancer (LARC) who have high-risk factors, such as low rectal cancer, clinical stage T4b, positive mesorectal fascia (MRF), and positive extramural vascular invasion (EMVI), are at extremely high risk of distant metastasis. For these LARC patients with high-risk factors, the pathological complete response (PCR) rate with neoadjuvant chemotherapy alone is relatively low, ranging from 4.3% to 13.3%. Therefore, the use of a more potent comprehensive neoadjuvant treatment regimen, including concurrent chemoradiotherapy combined with targeted therapy and immunotherapy, may offer greater benefits to these patients. For patients with high-risk LARC, this study aims to explore whether the combination of short-course radiotherapy, mFOLFOX6, PD-1 monoclonal antibody and cetuximab (for RAS/BRAF Wild-Type)/bevacizumab (for RAS/BRAF Mutant) can improve the pathological responce rate, and achieve better long-term survival benefits. The study will investigate the efficacy and safety of short-course radiotherapy, mFOLFOX6, PD-1 monoclonal antibody and cetuximab (for RAS/BRAF Wild-Type)/bevacizumab (for RAS/BRAF Mutant) for high-risk LARC.
Based on the above theoretical and clinical needs, we conducted a preliminary phase II exploratory study (the CRIT study). This study preliminarily validated the safety and excellent preliminary efficacy of the strategy of "short-course radiotherapy (SCRT) followed by mFOLFOX6 chemotherapy combined with RAS-guided targeted therapy and a PD-1 monoclonal antibody," achieving a pathological complete response (pCR) rate of 62.1% (66.7% in the RAS/BRAF wild-type subgroup and 57.1% in the RAS/BRAF mutant subgroup), which is much higher than historical controls, suggesting that this regimen has great clinical application value. Therefore, a phase III randomized controlled trial is being conducted.
Enrolled patients will be randomized into 2 groups with different treatment regimen. The control group will receive neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with four cycles of the mFOLFOX6 regimen. The experimental group will receive neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with four cycles of the mFOLFOX6 regimen, PD-1 monoclonal antibody, and molecularly targeted drugs (selected based on RAS status; patients with RAS/BRAF wild-type receive cetuximab, while those with RAS/BRAF mutations receive bevacizumab). After completing the first cycle of mFOLFOX6 chemotherapy (combined with targeted and immune therapy in the experimental group), patients undergo SCRT at a dose of 5Gy × 5 fractions. At least 7 days after the completion of radiotherapy, patients continue with three additional cycles of mFOLFOX6 chemotherapy (combined with PD-1 monoclonal antibody and targeted drugs in the experimental group). Bevacizumab is not used in the last cycle with RAS/BRAF mutations. Surgery is performed 8-10 weeks after the completion of SCRT. If pelvic MRI indicates clinical complete response (CCR) and N0, or T1N0M0, local excision (LE) will be performed. Otherwise, total mesorectal excision (TME) will be performed. The decision regarding adjuvant chemotherapy after surgery will be made by the attending physician.
- Conditions
- Rectal Adenocarcinoma, High-Risk Cancer, MSS
- Being tested
- Short-Course Radiotherapy, PD-1 monoclonal antibody, mFOLFOX6 regimen, Cetuximab, Bevacizumab
- Keywords
- Short-Course Radiotherapy, Targeting Therapy, Immunotherapy
- 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
Also called SCRT
Patients undergo SCRT at a dose of 5Gy × 5 fractions
PD-1 monoclonal antibodyDrug
Also called PD-1
Patients complete immune therapy with PD-1 monoclonal antibody for 4 cycles.
mFOLFOX6 regimenDrug
Also called mFOLFOX6
Patients complete chemotherapy with mFOLFOX6 regimen for 4 cycles.
CetuximabDrug
Also called Cetuximab Antibody
Patients with RAS/BRAF wild-type receive targeting therapy with Cetuximab for 4 cycles.
BevacizumabDrug
Also called Bevacizumab Antibody
Patients with RAS/BRAF mutations receive targeting therapy with Bevacizumab for 3 cycles. (Bevacizumab is not used in the last cycle of the bevacizumab group)
Surgical resectionProcedure or surgery
Also called Surgery
Surgery either local excition or total mesorectal excision is performed 8-10 weeks after the completion of short-course radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy | Experimental | The neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with four cycles of the mFOLFOX6 regimen, PD-1 monoclonal antibody, and molecularly targeted drugs (selected based on RAS status; patients with RAS/BRAF wild-type receive cetuximab, while those with RAS/BRAF mutations receive bevacizumab). After completing the first cycle of mFOLFOX6 chemotherapy combined with targeted and immune therapy, patients undergo SCRT at a dose of 5Gy × 5 fractions. At least 7 days after the completion of radiotherapy, patients continue with three additional cycles of mFOLFOX6 chemotherapy combined with PD-1 monoclonal antibody and targeted drugs (bevacizumab is not used in the last cycle of the bevacizumab group). Surgery is performed 8-10 weeks after the completion of SCRT. Receives: Radiation: Short-Course Radiotherapy; Drug: PD-1 monoclonal antibody; Drug: mFOLFOX6 regimen; Drug: Cetuximab; Drug: Bevacizumab; Procedure: Surgical resection |
| SCRT + mFOLFOX6 | Active comparator | The neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with four cycles of the mFOLFOX6 regimen. After completing the first cycle of mFOLFOX6 chemotherapy, patients undergo SCRT at a dose of 5Gy × 5 fractions. At least 7 days after the completion of radiotherapy, patients continue with three additional cycles of mFOLFOX6 chemotherapy. Surgery is performed 8-10 weeks after the completion of SCRT. Receives: Radiation: Short-Course Radiotherapy; Drug: mFOLFOX6 regimen; Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 years DFS Rate
3 years Disease Free Survival Rate
Measured: 3 years
Secondary outcomes (7)
pCR rate
pathological complete response rate
Measured: 1 year
3 years OS rate
3 years Overall Survival Rate
Measured: 3 years
3 years DMFS Rate
3 years Disease Metastasis Free Survival Rate
Measured: 3 years
3 years RFS Rate
3 years Recurrence Free Survival Rate
Measured: 3 years
R0 resection rate
R0 resection rate in participants
Measured: 1 year
Toxicities Associated with Neoadjuvant Therapy
incidence of adverse events related to neoadjuvant therapy as assessed by CTCAE v5.0
Measured: 1 year
CR rate
Complete response rate in participants
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start20 May 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Huang, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Jun Huang, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549399
- Sponsor's protocol ID
- E2026073
- Acronym
- CRITⅡ
- Status last verified
- Jun 2026
- First submitted
- 13 Apr 2026
- Last updated
- 1 Jul 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS/BRAF Wild-Type)/Bevacizumab (for RAS/BRAF Mutant) in High-Risk pMMR/MSS Rectal Adenocarcinoma: a Phase III Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07549399
- Acronym / sponsor ID
- CRITⅡ / E2026073
- Conditions
- Rectal Adenocarcinoma, High-Risk Cancer, MSS
- Keywords
- Short-Course Radiotherapy, Targeting Therapy, Immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 24 Apr 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.
To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS/BRAF status: cetuximab for wild-type, bevacizumab for mutant) and a PD-1 monoclonal antibody, compared with short-course radiotherapy followed by mFOLFOX6 chemotherapy alone, in high-risk locally advanced pMMR/MSS rectal adenocarcinoma through a prospective, randomized controlled phase III clinical study, providing high-level evidence-based medical evidence to establish a superior neoadjuvant treatment strategy for this population.
Detailed description
Patients with locally advanced rectal cancer (LARC) who have high-risk factors, such as low rectal cancer, clinical stage T4b, positive mesorectal fascia (MRF), and positive extramural vascular invasion (EMVI), are at extremely high risk of distant metastasis. For these LARC patients with high-risk factors, the pathological complete response (PCR) rate with neoadjuvant chemotherapy alone is relatively low, ranging from 4.3% to 13.3%. Therefore, the use of a more potent comprehensive neoadjuvant treatment regimen, including concurrent chemoradiotherapy combined with targeted therapy and immunotherapy, may offer greater benefits to these patients. For patients with high-risk LARC, this study aims to explore whether the combination of short-course radiotherapy, mFOLFOX6, PD-1 monoclonal antibody and cetuximab (for RAS/BRAF Wild-Type)/bevacizumab (for RAS/BRAF Mutant) can improve the pathological responce rate, and achieve better long-term survival benefits. The study will investigate the efficacy and safety of short-course radiotherapy, mFOLFOX6, PD-1 monoclonal antibody and cetuximab (for RAS/BRAF Wild-Type)/bevacizumab (for RAS/BRAF Mutant) for high-risk LARC.
Based on the above theoretical and clinical needs, we conducted a preliminary phase II exploratory study (the CRIT study). This study preliminarily validated the safety and excellent preliminary efficacy of the strategy of "short-course radiotherapy (SCRT) followed by mFOLFOX6 chemotherapy combined with RAS-guided targeted therapy and a PD-1 monoclonal antibody," achieving a pathological complete response (pCR) rate of 62.1% (66.7% in the RAS/BRAF wild-type subgroup and 57.1% in the RAS/BRAF mutant subgroup), which is much higher than historical controls, suggesting that this regimen has great clinical application value. Therefore, a phase III randomized controlled trial is being conducted.
Enrolled patients will be randomized into 2 groups with different treatment regimen. The control group will receive neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with four cycles of the mFOLFOX6 regimen. The experimental group will receive neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with four cycles of the mFOLFOX6 regimen, PD-1 monoclonal antibody, and molecularly targeted drugs (selected based on RAS status; patients with RAS/BRAF wild-type receive cetuximab, while those with RAS/BRAF mutations receive bevacizumab). After completing the first cycle of mFOLFOX6 chemotherapy (combined with targeted and immune therapy in the experimental group), patients undergo SCRT at a dose of 5Gy × 5 fractions. At least 7 days after the completion of radiotherapy, patients continue with three additional cycles of mFOLFOX6 chemotherapy (combined with PD-1 monoclonal antibody and targeted drugs in the experimental group). Bevacizumab is not used in the last cycle with RAS/BRAF mutations. Surgery is performed 8-10 weeks after the completion of SCRT. If pelvic MRI indicates clinical complete response (CCR) and N0, or T1N0M0, local excision (LE) will be performed. Otherwise, total mesorectal excision (TME) will be performed. The decision regarding adjuvant chemotherapy after surgery will be made by the attending physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy | Experimental | Radiation: Short-Course Radiotherapy, Drug: PD-1 monoclonal antibody, Drug: mFOLFOX6 regimen, Drug: Cetuximab, Drug: Bevacizumab, Procedure: Surgical resectionThe neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with four cycles of the mFOLFOX6 regimen, PD-1 monoclonal antibody, and molecularly targeted drugs (selected based on RAS status; patients with RAS/BRAF wild-type receive cetuximab, while those with RAS/BRAF mutations receive bevacizumab). After completing the first cycle of mFOLFOX6 chemotherapy combined with targeted and immune therapy, patients undergo SCRT at a dose of 5Gy × 5 fractions. At least 7 days after the completion of radiotherapy, patients continue with three additional cycles of mFOLFOX6 chemotherapy combined with PD-1 monoclonal antibody and targeted drugs (bevacizumab is not used in the last cycle of the bevacizumab group). Surgery is performed 8-10 weeks after the completion of SCRT. |
| SCRT + mFOLFOX6 | Active comparator | Radiation: Short-Course Radiotherapy, Drug: mFOLFOX6 regimen, Procedure: Surgical resectionThe neoadjuvant treatment phase includes short-course radiotherapy (SCRT) combined with four cycles of the mFOLFOX6 regimen. After completing the first cycle of mFOLFOX6 chemotherapy, patients undergo SCRT at a dose of 5Gy × 5 fractions. At least 7 days after the completion of radiotherapy, patients continue with three additional cycles of mFOLFOX6 chemotherapy. Surgery is performed 8-10 weeks after the completion of SCRT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulations and institutional guidelines.
- Age 18-75 years.
- Histologically or cytologically confirmed pMMR/MSS rectal adenocarcinoma; all other histological types are excluded.
- Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.
- Clinical staging with high-risk factors, including cT3Nx, EMVI(+), or cT4, ±MRF(+), ±EMVI(+).
Key exclusion criteria (17 listed)
- Patients with a history of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);
- Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;
- A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;
- Severe electrolyte abnormalities;
- Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or tumors with active bleeding that have not been resected; or other conditions that may lead to gastrointestinal bleeding or perforation; or gastrointestinal perforation that has not healed after surgical treatment;
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 RadiotherapyAlso: SCRTPatients undergo SCRT at a dose of 5Gy × 5 fractions | Radiation | SCRT + mFOLFOX6, SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy |
| PD-1 monoclonal antibodyAlso: PD-1Patients complete immune therapy with PD-1 monoclonal antibody for 4 cycles. | Drug | SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy |
| mFOLFOX6 regimenAlso: mFOLFOX6Patients complete chemotherapy with mFOLFOX6 regimen for 4 cycles. | Drug | SCRT + mFOLFOX6, SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy |
| CetuximabAlso: Cetuximab AntibodyPatients with RAS/BRAF wild-type receive targeting therapy with Cetuximab for 4 cycles. | Drug | SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy |
| BevacizumabAlso: Bevacizumab AntibodyPatients with RAS/BRAF mutations receive targeting therapy with Bevacizumab for 3 cycles. (Bevacizumab is not used in the last cycle of the bevacizumab group) | Drug | SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy |
| Surgical resectionAlso: SurgerySurgery either local excition or total mesorectal excision is performed 8-10 weeks after the completion of short-course radiotherapy. | Procedure or surgery | SCRT + mFOLFOX6, SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy |
Primary outcome
3 years DFS Rate
Time frame: 3 years
3 years Disease Free Survival Rate
7 secondary outcomes
pCR rate
Time frame: 1 year
3 years OS rate
Time frame: 3 years
3 years DMFS Rate
Time frame: 3 years
3 years RFS Rate
Time frame: 3 years
R0 resection rate
Time frame: 1 year
Toxicities Associated with Neoadjuvant Therapy
Time frame: 1 year
CR rate
Time frame: 1 year
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 1 Jul 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.
Jun Huang, PhD principal investigator
Sun Yat-sen University
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 Short-Course Radiotherapy, PD-1 monoclonal antibody and mFOLFOX6 regimen in people with Rectal Adenocarcinoma and High-Risk Cancer, run by Sixth Affiliated Hospital, 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 12 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: looking for participants now, as of the sponsor's last update on 1 Jul 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 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 Jun Huang, PhD. (+8613926451242, huangj97@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 years DFS Rate (time frame: 3 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 1 Jul 2026; AzTrials last refreshed its copy on 4 Nov 2026.