Locally Advanced Rectal CancerPhase 2CASINOsNCT06204094
Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer
A Phase 2 study testing node-sparing short-course radiotherapy, Sintilimab and Capecitabine in people with Locally Advanced Rectal Cancer, run by Jinhua Central Hospital at 1 site in China.
Trial summary
phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- node-sparing short-course radiotherapy, Sintilimab and Capecitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2024to 1 Sep 2028
- 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
- Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.
- Male or Female aged 18-75.
- Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT2N+M0/cT3-4N0/+M0, the lymph nodes are limited to the mesorectum.
- Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.
- Eastern Cooperative Oncology Group (ECOG) 0-1.
- No previous treatment(including anti-tumor therapy、immunotherapy or pelvic radiation).
- Adequate hematologic, hepatic, renal, thyroid and cardiac function: white blood cells ≥3500/mm3, neutrophils ≥1800/mm3, platelets ≥100,000/mm3, hemoglobin ≥100 g/L; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.25 × ULN, serum albumin ≥28 g/L. creatinine clearance ≥50 mL/mi, creatinine ≤1.5 × ULN;
- Informed consent form signed.
Who cannot join
- Patients with a previous history of malignant tumors besides rectal cancer.
- Patients with distant metastases before enrollment.
- Patients with positive internal or external iliac lymph nodes are assessed by MRI or CT.
- Patients with obstruction, perforation, or bleeding that require emergency surgery.
- Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
- Allergic to any component of the therapy.
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- Patients with poorly differentiated adenocarcinoma, signet ring cell carcinoma, or mucinous adenocarcinoma.
- Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy.
- Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening.
- Factors leading to study termination, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) requiring combination therapy, and patients with severe laboratory abnormalities.
- Patients with congenital or acquired immune deficiency (such as HIV infection).
- Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc.
- Other conditions that investigators consider not suitable for this study.
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
Zhejiang University Affiliated Jinhua Hospital
Jinhua, Zhejiang, 0579
Cheng Cai, master degree, 86+18395995912, ColoSurg_cc@zju.edu.cn
About this study
Official title: Total Neoadjuvant CAPOX And PD-1 Inhibitor（Sintilimab） Combined With Node-sparing Short-course Radiotherapy For MSS Locally Advanced Of Middle And Low Rectal Cancer(CASINOs): An Open Label, Single-arm, Prospective Clinical Trial
phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.
Read the detailed description
This is an open-label, prospective, single-center phase II clinical trial to evaluate node-sparing short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with total neoadjuvant CAPOX and PD-1 Inhibitor (Sintilimab) for patients with MSS locally advanced of middle and low rectal cancer. A total of 37 patients will be enrolled in this trial. The primary endpoint is the complete response(CR) rate, which includes cCR and pCR. The organ preservation rate, tumor regression grade, 3-year DFS, 3-year OS, and adverse effects will also be analyzed.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- node-sparing short-course radiotherapy, Sintilimab, Capecitabine, Oxaliplatin, TME surgery
- Keywords
- rectal cancer, microsatellite stability, node-sparing, CAPOX, radiotherapy, sintilimab, immunotherapy, neoadjuvant
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
node-sparing short-course radiotherapyRadiation
5Gy*5d, radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes
SintilimabDrug
Also called IBI308
200mg intravenous infusion d1 of each cycle*6cycles
CapecitabineDrug
1000mg/m2, PO, BID, d1-14 of each cycle*6cycles
OxaliplatinDrug
130mg/m2, intravenous infusion,d1 of each cycle*6cycles
TME surgeryProcedure or surgery
Also called total mesorectal excision
laparoscopic or robotic TME surgery for non-cCR patients
watch and waitProcedure or surgery
Also called WW
WW for cCR patients
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Participants will receive 5*5Gy node-sparing short-course radiation (radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) concurrently with total neoadjuvant CAPOX and sintilimab regimens: Oxaliplatin, 130mg/m2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg/m2, PO, BID, d1-14 and sintilimab, 200mg intravenous infusion d1 of each cycle. CAPOX and sintilimab are repeated every 3 weeks for 6 cycles. Patients with cCR will be managed with a WW strategy, and patients who did not achieve cCR will receive TME surgery.
Interventions:
* Radiation: node-sparing short-course radiation
* Drug: PD-1 antibody (Sintilimab)
* Drug: Capecitabine
* Drug: Oxaliplatin Receives: Radiation: node-sparing short-course radiotherapy; Drug: Sintilimab; Drug: Capecitabine; Drug: Oxaliplatin; Procedure: TME surgery; Procedure: watch and wait |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response
Pathological complete response (pCR) ：absence of residual tumour on resected specimen. Clinical complete response（cCR）: no residual tumour visible on imaging or colonoscopy and biopsy.
Measured: within 10 days after TNT therapy or surgery
Secondary outcomes (8)
Tumor regression grade
TRG is evaluated according to the AJCC system. TRG0-1 is defined as good response, TRG2 as moderate response, and TRG3 as poor response.
Measured: within 10 days after surgery
Local recurrence rate(LRR)
Presence of adenocarcinoma within the rectal wall or within the mesorectum confirmed by pathology.
Measured: 3 years after sugery
Disease free survival(DFS)
the time from randomization to recurrence of tumor or death
Measured: 3 years after treatment
Overall survival(OS)
the time from randomization to death
Measured: 3 years after enrollment
Adverse effects rate
Rate of radiotherapy, chemotherapy and immunotherapy related adverse events
Measured: From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
Rectal specific quality of life assessment via QLQ-CR29
Rectal specific quality of life according to European Organization for Research and Treatment of Cancer ( EORTC) Quality of life questionnaire QLQ-CR29. scale from 0 to 100, A higher scale represents better function and a higher quality of life.
Measured: Baseline and months 3, 6, 12, 24, 36, 60 after the TNT treatment or surgery
Quality of life assessment via QLQ-C30
Quality of life according to EORTC Quality of life Questionnaire QLQ-C30 version 3.0. Score range from 0 to 100 points. A higher score represents better function and a higher quality of life.
Measured: Baseline and months 3, 6, 12, 24, 36, 60 after the TNT treatment or surgery
Validation of the Wexner score
The change of severity of fecal incontinence assessment according to Wexner score. a score from 0-20, where 0 is perfect continence and 20 is complete incontinence.
Measured: Months 3, 6, 12, 24, 36, 60 after the TNT treatment or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start5 Feb 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (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.
- 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
- Model description
- Radiation: node-sparing short-course radiotherapy (5Gy\*5d) Drug: PD-1 antibody (Sintilimab) Drug: Capecitabine Drug: Oxaliplatin
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinhua Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Cai, Jinhua Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204094
- Sponsor's protocol ID
- Jinhua CH
- Acronym
- CASINOs
- Status last verified
- Apr 2026
- First submitted
- 2 Jan 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: JinhuaCH will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Neoadjuvant CAPOX And PD-1 Inhibitor（Sintilimab） Combined With Node-sparing Short-course Radiotherapy For MSS Locally Advanced Of Middle And Low Rectal Cancer(CASINOs): An Open Label, Single-arm, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06204094
- Acronym / sponsor ID
- CASINOs / Jinhua CH
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- rectal cancer, microsatellite stability, node-sparing, CAPOX, radiotherapy, sintilimab, immunotherapy, neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Jinhua Central HospitalUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 12 Jan 2024 (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.
phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.
Detailed description
This is an open-label, prospective, single-center phase II clinical trial to evaluate node-sparing short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with total neoadjuvant CAPOX and PD-1 Inhibitor (Sintilimab) for patients with MSS locally advanced of middle and low rectal cancer. A total of 37 patients will be enrolled in this trial. The primary endpoint is the complete response(CR) rate, which includes cCR and pCR. The organ preservation rate, tumor regression grade, 3-year DFS, 3-year OS, and adverse effects will also be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Radiation: node-sparing short-course radiotherapy (5Gy*5d) Drug: PD-1 antibody (Sintilimab) Drug: Capecitabine Drug: Oxaliplatin
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Radiation: node-sparing short-course radiotherapy, Drug: Sintilimab, Drug: Capecitabine, Drug: Oxaliplatin, Procedure: TME surgery, Procedure: watch and waitParticipants will receive 5*5Gy node-sparing short-course radiation (radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) concurrently with total neoadjuvant CAPOX and sintilimab regimens: Oxaliplatin, 130mg/m2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg/m2, PO, BID, d1-14 and sintilimab, 200mg intravenous infusion d1 of each cycle. CAPOX and sintilimab are repeated every 3 weeks for 6 cycles. Patients with cCR will be managed with a WW strategy, and patients who did not achieve cCR will receive TME surgery. Interventions: * Radiation: node-sparing short-course radiation * Drug: PD-1 antibody (Sintilimab) * Drug: Capecitabine * Drug: Oxaliplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.
- Male or Female aged 18-75.
- Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT2N+M0/cT3-4N0/+M0, the lymph nodes are limited to the mesorectum.
- Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.
- Eastern Cooperative Oncology Group (ECOG) 0-1.
Key exclusion criteria (13 listed)
- Patients with a previous history of malignant tumors besides rectal cancer.
- Patients with distant metastases before enrollment.
- Patients with positive internal or external iliac lymph nodes are assessed by MRI or CT.
- Patients with obstruction, perforation, or bleeding that require emergency surgery.
- Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
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 |
|---|---|---|
| node-sparing short-course radiotherapy5Gy*5d, radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes | Radiation | Treatment Arm |
| SintilimabAlso: IBI308200mg intravenous infusion d1 of each cycle*6cycles | Drug | Treatment Arm |
| Capecitabine1000mg/m2, PO, BID, d1-14 of each cycle*6cycles | Drug | Treatment Arm |
| Oxaliplatin130mg/m2, intravenous infusion,d1 of each cycle*6cycles | Drug | Treatment Arm |
| TME surgeryAlso: total mesorectal excisionlaparoscopic or robotic TME surgery for non-cCR patients | Procedure or surgery | Treatment Arm |
| watch and waitAlso: WWWW for cCR patients | Procedure or surgery | Treatment Arm |
Primary outcome
Complete response
Time frame: within 10 days after TNT therapy or surgery
Pathological complete response (pCR) ：absence of residual tumour on resected specimen. Clinical complete response（cCR）: no residual tumour visible on imaging or colonoscopy and biopsy.
8 secondary outcomes
Tumor regression grade
Time frame: within 10 days after surgery
Local recurrence rate(LRR)
Time frame: 3 years after sugery
Disease free survival(DFS)
Time frame: 3 years after treatment
Overall survival(OS)
Time frame: 3 years after enrollment
Adverse effects rate
Time frame: From date of initiation of treatment until the date of death from any cause, assessed up to 5 years
Rectal specific quality of life assessment via QLQ-CR29
Time frame: Baseline and months 3, 6, 12, 24, 36, 60 after the TNT treatment or surgery
Quality of life assessment via QLQ-C30
Time frame: Baseline and months 3, 6, 12, 24, 36, 60 after the TNT treatment or surgery
Validation of the Wexner score
Time frame: Months 3, 6, 12, 24, 36, 60 after the TNT treatment or surgery
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 24 Apr 2026.
- Individual participant dataSharing planned: Yes. JinhuaCH will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
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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 node-sparing short-course radiotherapy, Sintilimab and Capecitabine in people with Locally Advanced Rectal Cancer, run by Jinhua Central 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 8 inclusion and 13 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 24 Apr 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 jinlin du, master (86 13957998111, djl9090@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response (time frame: within 10 days after TNT therapy or surgery). 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 24 Apr 2026.