Locally Advanced Rectal Cancer (LARC)NCT07738042
To Explore a Single-arm Phase II Study on Intestinal Microbiota Transplantation Combined With Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Rectal Cancer Under MSS/pMMR
A study testing Sintilimab, CAPOX (oxaliplatin/capecitabine) and Short-course radiotherapy in people with Locally Advanced Rectal Cancer (LARC), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
To evaluate the pathological complete response rate (pCR) of intestinal flora transplantation combined with short-course radiotherapy +CAPOX+ sintilimab in neoadjuvant therapy for locally advanced rectal cancer (pMMR/MSS type) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer (LARC)
- What is being tested?
- Sintilimab, CAPOX (oxaliplatin/capecitabine) and Short-course radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2026to 31 Dec 2030
- Phase
- Interventional
- 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
- ECOG PS 0-1
- The lower edge of the tumor is ≤12cm from the anal margin. After multidisciplinary assessment, R0 resection is possible
- RAS/BRAF wild type, pMMR/MSS status
- Patients of childbearing age need to take effective contraceptive measures.
- Voluntarily sign the informed consent form
Who cannot join
- dMMR/MSI-H type
- Has previously received anti-tumor treatment (including surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy);
- Active autoimmune diseases, inflammatory bowel disease;
- Active infection, immune deficiency, severe liver and kidney dysfunction;
- Severe intestinal obstruction, perforation or requiring emergency surgery;
- Pregnant or lactating women;
- Contraindications related to FMT (such as recent use of high-dose immunosuppressants, severe neutropenia, etc.);
- Other circumstances where participation in clinical trials is not suitable
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
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Zhansheng Jiang, 008618526812877, 18526812877@163.com
Zhansheng Jiang
About this study
To evaluate the pathological complete response rate (pCR) of intestinal flora transplantation combined with short-course radiotherapy +CAPOX+ sintilimab in neoadjuvant therapy for locally advanced rectal cancer (pMMR/MSS type)
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Being tested
- Sintilimab, CAPOX (oxaliplatin/capecitabine), Short-course radiotherapy, Intestinal bacteria transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab 200mg Q3W 2 cycles
CAPOX (oxaliplatin/capecitabine)Drug
CAPOX Q3W 2 cycles
Short-course radiotherapyRadiation
Short-course radiotherapy 25Gy/5 doses, completed within one week
Intestinal bacteria transplantationBiological
Intestinal bacteria transplantation Q3W 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: Sintilimab; Drug: CAPOX (oxaliplatin/capecitabine); Radiation: Short-course radiotherapy; Biological: Intestinal bacteria transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response rate
Measured: After surgery, an average of 1-2 weeks
Secondary outcomes (5)
Objective response rate
Measured: After the drug treatment is completed, an average of 1-2 weeks
Major Pathological Response
Measured: After surgery, an average of 1-2 weeks
R0 resection rate
Measured: After surgery, an average of 1-2 weeks
sphincter-preserving rate
Measured: After surgery, an average of 1-2 weeks
Safety（Adverse reactions）
Measured: During the treatment period, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (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 Cancer (LARC)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738042
- Sponsor's protocol ID
- LARC-BCAPOX
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore a Single-arm Phase II Study on Intestinal Microbiota Transplantation Combined With Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Rectal Cancer Under MSS/pMMR
- ClinicalTrials.gov ID
- NCT07738042
- Acronym / sponsor ID
- LARC-BCAPOX
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 30 Jul 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 evaluate the pathological complete response rate (pCR) of intestinal flora transplantation combined with short-course radiotherapy +CAPOX+ sintilimab in neoadjuvant therapy for locally advanced rectal cancer (pMMR/MSS type)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Sintilimab, Drug: CAPOX (oxaliplatin/capecitabine), Radiation: Short-course radiotherapy, Biological: Intestinal bacteria transplantation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ECOG PS 0-1
- The lower edge of the tumor is ≤12cm from the anal margin. After multidisciplinary assessment, R0 resection is possible
- RAS/BRAF wild type, pMMR/MSS status
- Patients of childbearing age need to take effective contraceptive measures.
- Voluntarily sign the informed consent form
Key exclusion criteria (8 listed)
- dMMR/MSI-H type
- Has previously received anti-tumor treatment (including surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy);
- Active autoimmune diseases, inflammatory bowel disease;
- Active infection, immune deficiency, severe liver and kidney dysfunction;
- Severe intestinal obstruction, perforation or requiring emergency surgery;
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 |
|---|---|---|
| SintilimabSintilimab 200mg Q3W 2 cycles | Drug | Treatment group |
| CAPOX (oxaliplatin/capecitabine)CAPOX Q3W 2 cycles | Drug | Treatment group |
| Short-course radiotherapyShort-course radiotherapy 25Gy/5 doses, completed within one week | Radiation | Treatment group |
| Intestinal bacteria transplantationIntestinal bacteria transplantation Q3W 2 cycles | Biological | Treatment group |
Primary outcome
Pathological Complete Response rate
Time frame: After surgery, an average of 1-2 weeks
5 secondary outcomes
Objective response rate
Time frame: After the drug treatment is completed, an average of 1-2 weeks
Major Pathological Response
Time frame: After surgery, an average of 1-2 weeks
R0 resection rate
Time frame: After surgery, an average of 1-2 weeks
sphincter-preserving rate
Time frame: After surgery, an average of 1-2 weeks
Safety（Adverse reactions）
Time frame: During the treatment period, up to 3 months
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 30 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sintilimab, CAPOX (oxaliplatin/capecitabine) and Short-course radiotherapy in people with Locally Advanced Rectal Cancer (LARC), run by Tianjin Medical University Cancer Institute and 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 5 inclusion and 8 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 30 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.
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 Zhansheng Jiang (008618526812877, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response rate (time frame: After surgery, an average of 1-2 weeks). 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 30 Jul 2026.