Neoadjuvant Chemoradiation TherapyPhase 2/3NCT05215379
Neoadjuvant Chemoradiation Therapy Combined With Immunotherapy for MSS Ultra-low Rectal Cancer
A Phase 2/3 study testing xintilimab injection in people with Neoadjuvant Chemoradiation Therapy and Rectal Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
At present, there are no relevant studies or reports on the effect of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer. Studied in this paper combin neoadjuvant chemoradiation with immune therapy, carry out "Multicenter prospective randomized clinical trial of neoadjuvant… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoadjuvant Chemoradiation Therapy, Rectal Cancer, Immunotherapy
- What is being tested?
- xintilimab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 24 Jun 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- Ultra low rectal cancer patients evaluated by multidisciplinary team to perform APR
- Patients who have a strong desire to preserve the anus and are willing to accept neoadjuvant treatment
- 18 years old ≤ age ≤ 75 years old, no gender limit;
- Colonoscopy, intracavitary ultrasound and pelvic high-resolution MRI (or enhanced CT) were diagnosed as extremely low rectal cancer within 5 cm from the lower edge of the tumor to the anal edge. The baseline clinical stage is T1-3aN0-1M0, and the size of the tumor <1/2 circle;
- Histopathological diagnosis of rectal adenocarcinoma; tumor biopsy immunohistochemistry showed pMMR, that is, MSH1, MSH2, MSH6 and PMS2 four proteins are positive, or genetic testing suggests MSI-L or MSS.
- The patient has good compliance and can come to the hospital for reexamination as required;
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- ECOG physical status score 0-1 points;
- Have not received anti-tumor and immunotherapy before being selected;
- 8. Laboratory inspections must meet the following standards: i. White blood cell count ≥3.5×109/L, absolute neutrophil count ≥1.8×109/L, platelet count ≥100×10^9/L, hemoglobin ≥100g/L; ii. INR≤1.5, and APTT≤1.5 times the upper limit of normal value or partial prothrombin time (PTT)≤1.5 times the upper limit of normal value; iii. Total bilirubin≤1.25 times the upper limit of normal; ALT and AST≤5 times the upper limit of normal; iv. 24h creatinine clearance rate ≥50mL/min or blood creatinine ≤1.5 times the upper limit of normal.
- Voluntarily sign the informed consent form;
Who cannot join
- History of other malignant diseases in the past 5 years;
- Patients with metastases ;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
- Those who are known to be allergic to capecitabine, oxaliplatin, PD-1 monoclonal antibody and other drugs;
- Patients with poorly differentiated adenocarcinoma, signet ring cell carcinoma, and mucinous adenocarcinoma;
- The patient is accompanied by any unstable systemic diseases, including but not limited to: severe infection, uncontrolled diabetes, hypertension that cannot be controlled by drugs, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardium Infarction, congestive heart failure, severe arrhythmia requiring medication, liver, kidney or metabolic diseases; diseases that affect the life of the patient.
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- The patient's accompanying diseases (such as mental illness, etc.) or conditions (such as alcohol or drug abuse, etc.) will increase the patient's risk of receiving experimental drug treatment or affect the patient's compliance with the trial requirements, or may confuse the research results;
- Within 30 days before screening, the patient has received any other experimental drug treatment or participated in another interventional clinical trial;
- Women who are pregnant or breastfeeding or who intend to become pregnant or breastfeeding during the study period; men or women who are unwilling to take effective contraceptive measures;
- The investigator judges that the patient is not suitable to participate in other situations such as the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Colorectal Surgery in Changhai Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official title: Multicenter Prospective Randomized Clinical Trial of Neoadjuvant Chemoradiation Therapy Combined With Immunotherapy for MSS Ultra-low Rectal Cancer
At present, there are no relevant studies or reports on the effect of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer. Studied in this paper combin neoadjuvant chemoradiation with immune therapy, carry out "Multicenter prospective randomized clinical trial of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer" in order to provide a high-level evidence-based medical evidence for ultra-low rectal cancer treatment and improve ultra-low rectal cancer diagnosis and treatment effect.
- Conditions
- Neoadjuvant Chemoradiation Therapy, Rectal Cancer, Immunotherapy, Microsatellite Instability Low
- Being tested
- xintilimab injection, Control
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xintilimab injectionDrug
neoadjuvant chemoradiation therapy +xintilimab injection 200mg/3week 4cycle
ControlOther
neoadjuvant chemoradiation therapy
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant chemoradiation therapy | Other | neoadjuvant chemoradiation therapy Receives: Other: Control |
| neoadjuvant chemoradiation therapy +immunotherapy | Experimental | neoadjuvant chemoradiation therapy +immunotherapy Receives: Drug: xintilimab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of cCR
Rate of patients who achieve clinical complete response
Measured: 2 years
Secondary outcomes (6)
The rate of organ preservation
Rate of patients who achieve organ preservation
Measured: 2 years
The rate of anus preservation
Rate of patients who achieve anus preservation
Measured: 2 years
pCR rate
Rate of pCR patients after surgery
Measured: 2 years
Disease free survival(DFS)
DFS was defined as the duration from the date of randomization to the date of the first recurrence (local, distant, or mixed) or death.
Measured: 2 years
overall survival(OS)
OS was calculated from the date of randomization.
Measured: 2 years
Quality of life
The QoL was assessed by EORTC QOL Core Questionnaire.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Oct 2022
- Primary completion30 Dec 2024
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoadjuvant Chemoradiation TherapyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215379
- Sponsor's protocol ID
- CHCRS-Immunity
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2022
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD would be available upon reasonable request.
Publications
Zhou L, Yu G, Wen R, Jia H, Zhang T, Peng Z, Fan H, Pan A, Yu Y, Zhu X, Gong H, Gao X, Lou Z, Zhang W. Neoadjuvant chemoradiation therapy combined with immunotherapy for microsatellite stable ultra-low rectal cancer (CHOICE II): study protocol of a multicentre prospective randomised clinical trial. BMJ Open. 2023 Sep 13;13(9):e069793. doi: 10.1136/bmjopen-2022-069793.
PubMed 37709314
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Randomized Clinical Trial of Neoadjuvant Chemoradiation Therapy Combined With Immunotherapy for MSS Ultra-low Rectal Cancer
- ClinicalTrials.gov ID
- NCT05215379
- Acronym / sponsor ID
- CHCRS-Immunity
- Conditions
- Neoadjuvant Chemoradiation Therapy, Rectal Cancer, Immunotherapy, Microsatellite Instability Low
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 31 Jan 2022 (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.
At present, there are no relevant studies or reports on the effect of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer. Studied in this paper combin neoadjuvant chemoradiation with immune therapy, carry out "Multicenter prospective randomized clinical trial of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer" in order to provide a high-level evidence-based medical evidence for ultra-low rectal cancer treatment and improve ultra-low rectal cancer diagnosis and treatment effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant chemoradiation therapy | Other | Other: Controlneoadjuvant chemoradiation therapy |
| neoadjuvant chemoradiation therapy +immunotherapy | Experimental | Drug: xintilimab injectionneoadjuvant chemoradiation therapy +immunotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ultra low rectal cancer patients evaluated by multidisciplinary team to perform APR
- Patients who have a strong desire to preserve the anus and are willing to accept neoadjuvant treatment
- 18 years old ≤ age ≤ 75 years old, no gender limit;
- Colonoscopy, intracavitary ultrasound and pelvic high-resolution MRI (or enhanced CT) were diagnosed as extremely low rectal cancer within 5 cm from the lower edge of the tumor to the anal edge. The baseline clinical stage is T1-3aN0-1M0, and the size of the tumor <1/2 circle;
- Histopathological diagnosis of rectal adenocarcinoma; tumor biopsy immunohistochemistry showed pMMR, that is, MSH1, MSH2, MSH6 and PMS2 four proteins are positive, or genetic testing suggests MSI-L or MSS.
Key exclusion criteria (10 listed)
- History of other malignant diseases in the past 5 years;
- Patients with metastases ;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
- Those who are known to be allergic to capecitabine, oxaliplatin, PD-1 monoclonal antibody and other drugs;
- Patients with poorly differentiated adenocarcinoma, signet ring cell carcinoma, and mucinous adenocarcinoma;
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 |
|---|---|---|
| xintilimab injectionneoadjuvant chemoradiation therapy +xintilimab injection 200mg/3week 4cycle | Drug | neoadjuvant chemoradiation therapy +immunotherapy |
| Controlneoadjuvant chemoradiation therapy | Other | neoadjuvant chemoradiation therapy |
Primary outcome
The rate of cCR
Time frame: 2 years
Rate of patients who achieve clinical complete response
6 secondary outcomes
The rate of organ preservation
Time frame: 2 years
The rate of anus preservation
Time frame: 2 years
pCR rate
Time frame: 2 years
Disease free survival(DFS)
Time frame: 2 years
overall survival(OS)
Time frame: 2 years
Quality of life
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Derived from this study: PubMed 37709314Zhou L, Yu G, Wen R, Jia H, Zhang T, Peng Z, Fan H, Pan A, Yu Y, Zhu X, Gong H, Gao X, Lou Z, Zhang W. Neoadjuvant chemoradiation therapy combined with immunotherapy for microsatellite stable ultra-low rectal cancer (CHOICE II): study protocol of a multicentre prospective randomised clinical trial. BMJ Open. 2023 Sep 13;13(9):e069793. doi: 10.1136/bmjopen-2022-069793.
- Individual participant dataSharing planned: Yes. IPD would be available upon reasonable 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing xintilimab injection in people with Neoadjuvant Chemoradiation Therapy and Rectal Cancer, run by Changhai 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 2 Jan 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 combined 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of cCR (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05215379, which also lists 1 linked publication.
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 2 Jan 2026.