Locally Advanced Rectal CarcinomaPhase 2/3NCT06312982
A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer
A Phase 2/3 study testing Tislelizumab in people with Locally Advanced Rectal Carcinoma, run by Beijing Friendship Hospital at 2 sites in China.
Trial summary
The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Carcinoma
- What is being tested?
- Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 2 sitesChina
- Study dates
- 16 Mar 2024to 1 Dec 2026
- Phase
- Phase 2/3
- 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
- Signed a written informed consent form and volunteered to join the study;
- .Age: 18-75 years old, male or female;
- Pathohistologically confirmed rectal adenocarcinoma, along with immunohistochemical results of pMMR or genetic test results of MSS;
- The baseline clinical stage assessed by MRI was T1-2N1-2M0 or T3N0-2M0, MRF (-), lateral lymph nodes (-);
- The lower tumor margin is 10cm away from the anal margin;
- Surgical resection;
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- Ability to swallow tablets normally;
- ECOG PS 0-1；
- Have not received any anti-tumor treatment for rectal cancer, including radiotherapy, chemotherapy, surgery, etc.;
- Plan to undergo surgery after the completion of the neoadjuvant therapy;
- No contraindications to surgery;
- Main organ function is normal.
Who cannot join
- Previous history of allergy to monoclonal antibodies, any component of tislelizumab,and capecitabine;
- Previously has received or is receiving any of the following treatments:
- A)Any tumor-specific surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc; B)Treatment with immunosuppressive drugs or systemic hormones within 2 weeks of first use (dose> 10mg / day prednisone or equivalent dose); inhaled or topical steroids and dose> 10mg / day prednisone or equivalent dose of adrenocorticoid replacement in the absence of active autoimmune disease; C)Having received a live attenuated vaccine within 4 weeks before the first use of the study drug; D)Major surgery or severe trauma within 4 weeks before the first use of study drug;
- History of any active autoimmune or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered after hormone replacement therapy); patients with psoriasis or asthma / allergy in childhood and adults without any intervention, but patients requiring medical intervention with bronchodilators should not be included;
- A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;
- Not well controlled cardiac clinical symptoms or disease, including but not limited to: such as (1) grade NYHA II above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinical meaningful supraventricular or ventricular arrhythmia without clinical intervention or clinical intervention still poor control;
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- Severe infection (Grade CTCAE> 2) within 4 weeks prior to the first use of study drug, Such as severe pneumonia, bacteremia, infection complications requiring hospitalization; Baseline chest imaging indicated the presence of active lung inflammation, presence of symptoms and signs and signs of infection within 14 days prior to the first administration of study drug or need for oral or intravenous antibiotics, Except for the preventive use of antibiotics; Found active tuberculosis infection by history or CT, Or those with a history of active tuberculosis infection within 1 year prior to enrollment, Or those with a history of active tuberculosis infection more than 1 year ago but without formal treatment;
- Presence of active hepatitis B (HBV DNA 2000 IU / mL or 104copies / mL), hepatitis C (positive for hepatitis C antibody, and HCV RNA above the lower limit of detection of the analytical method);
- A diagnosis of other malignancies within 5 years prior to the first use of study drug, unless a malignancy with low risk of metastasis or death (5-year survival> 90%), such as adequately treated skin basal cell carcinoma or squamous cell carcinoma in situ, are considered;
- Women in pregnancy or lactation;
- Other factors, as judged by the investigator, may lead to forced termination of the study, such as other serious illness (including mental illness), alcohol, substance abuse, family or social factors, which may affect the safety or compliance of the subject.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Yao Hongwei, M.D, 86 13611015609, yaohongwei@ccmu.edu.cn
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Zhongtao Zhang,, MD, +86-13801060364, zhangzht@ccmu.edu.cn
About this study
Official title: A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer: From a Multicenter Phase II Cohort to a Phase III Randomized Controlled Study
The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer.
The main questions it aims to answer are:
To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer To assess rectal or anal retention as well as quality of life. Participants will receive a long course of NCRT (50 Gy / 25f, capecitabine 850-1000 mg / m2, BID, PO, D1-D5, QW) within the first 5 weeks. In regard to tumor immunotherapy, enrolled patients will receive tislelizumab (200 mg, iv) on the first day at week 2,5, and 8 after initiation of radiotherapy. Thereafter, patients will be treated with two 14-day cycles of the CAPOX（Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt; D1-D14, capecitabine, 850-1000mg / m2, BID, PO）regimen. Two CAOPX regimens were treated one week apart.
- Conditions
- Locally Advanced Rectal Carcinoma
- Being tested
- Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Enrolled patients will receive tislelizumab 3 times after initiation of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The enrolled patients will receive a long course of NCRT (50 Gy / 25f, capecitabine 850-1000 mg / m2, BID, PO, D1-D5, QW) within the first 5 weeks. In regard to tumor immunotherapy, enrolled patients will receive tislelizumab (200 mg, iv) on the first day at week 2,5, and 8 after initiation of radiotherapy. Thereafter, patients will be treated with two 14-day cycles of the CAPOX（Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt; D1-D14, capecitabine, 850-1000mg / m2, BID, PO）regimen. Two CAOPX regimens were treated one week apart. Eight to 8-10 weeks after the completion of radiation therapy, patients will undergo multiple examinations, including colonoscopy and MRI. Subsequent treatment options will be determined by each center physician based on their clinical experience. Receives: Drug: Tislelizumab |
| Control group | No intervention | This group required only 5 weeks of NCRT and two 14-day cycles of the CAPOX （Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt; D1-D14, capecitabine, 850-1000mg / m2, BID, PO）regimen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR
complete response rate=(number of pathological complete responses + number of clinical complete responses)/total number of patients
Measured: pCR :within 10 days after surgery;cCR :13 weeks after radiotherapy begins
Secondary outcomes (5)
AE rate
Adverse event rate
Measured: during treatment
NAR score
Neoadjuvant rectal（NAR）score：It is based on the scoring criteria of preoperative treatment
Measured: within 10 days after surgery
ORR
objective response rate
objective response rate
objective response rate
objective response rate
Measured: within 10 days after surgery
OPR
organ preservation rate
organ preservation rate
organ preservation rate
Measured: immediately after surgery
immune-related adverse event rate
adverse event rate that is deemed to be associated with tislelizumab
Measured: up to 3 weeks after using tislelizumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start16 Mar 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Peking University Cancer Hospital & Institute, China-Japan Friendship Hospital, Peking Union Medical College Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Fudan University, Changhai Hospital, RenJi Hospital, Sir Run Run Shaw Hospital, Shandong Provincial Hospital, Zhongnan Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Academy of Medical Sciences, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Hospital of Jilin University, First Hospital of China Medical University, Xijing Hospital of Airforce Medical University, The Second Affiliated Hospital of Air Force Military Medical University, The Affiliated Hospital of Qingdao University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Tianjin Union Medical Center, The First Affiliated Hospital of Shanxi Medical University, Sixth Affiliated Hospital, Sun Yat-sen University, The Affiliated Tumour Hospital of China Academy of Medical Science, PLA Rocket Force Characteristic Medical Center, Tianjin Medical University General Hospital, The Second Affiliated Hospital of Naval Medical University, West China Hospital, Southern Medical University, China, First Affiliated Hospital of Chongqing Medical University, The First Affiliated Hospital of Anhui Medical University, Hebei Medical University Fourth Hospital, Sun Yat-Sen University Cancer Center, Zhejiang Tumor Hospital, Ruijin Hospital, Beijing Hospital of the Ministry of Health, Queen Mary Hospital, Hong Kong, The University of Hong Kong-Shenzhen Hospital, Taiwan Hexin Cancer Center Hospital, First Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312982
- Sponsor's protocol ID
- BFH-niCRT-04
- Status last verified
- Jul 2025
- First submitted
- 9 Mar 2024
- Last updated
- 13 Jan 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer: From a Multicenter Phase II Cohort to a Phase III Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06312982
- Acronym / sponsor ID
- BFH-niCRT-04
- Conditions
- Locally Advanced Rectal Carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Peking University Cancer Hospital & Institute, China-Japan Friendship Hospital, Peking Union Medical College Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Fudan University, Changhai Hospital, RenJi Hospital, Sir Run Run Shaw Hospital, Shandong Provincial Hospital, Zhongnan Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Academy of Medical Sciences, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Hospital of Jilin University, First Hospital of China Medical University, Xijing Hospital of Airforce Medical University, The Second Affiliated Hospital of Air Force Military Medical University, The Affiliated Hospital of Qingdao University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Tianjin Union Medical Center, The First Affiliated Hospital of Shanxi Medical University, Sixth Affiliated Hospital, Sun Yat-sen University, The Affiliated Tumour Hospital of China Academy of Medical Science, PLA Rocket Force Characteristic Medical Center, Tianjin Medical University General Hospital, The Second Affiliated Hospital of Naval Medical University, West China Hospital, Southern Medical University, China, First Affiliated Hospital of Chongqing Medical University, The First Affiliated Hospital of Anhui Medical University, Hebei Medical University Fourth Hospital, Sun Yat-Sen University Cancer Center, Zhejiang Tumor Hospital, Ruijin Hospital, Beijing Hospital of the Ministry of Health, Queen Mary Hospital, Hong Kong, The University of Hong Kong-Shenzhen Hospital, Taiwan Hexin Cancer Center Hospital, First Affiliated Hospital of Wenzhou Medical University
- Study start
- 16 Mar 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 15 Mar 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.
The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer.
The main questions it aims to answer are:
To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tirelizumab compared with neoadjuvant chemoradiotherapy alone for neoadjuvant therapy in patients with locally advanced rectal cancer To assess rectal or anal retention as well as quality of life. Participants will receive a long course of NCRT (50 Gy / 25f, capecitabine 850-1000 mg / m2, BID, PO, D1-D5, QW) within the first 5 weeks. In regard to tumor immunotherapy, enrolled patients will receive tislelizumab (200 mg, iv) on the first day at week 2,5, and 8 after initiation of radiotherapy. Thereafter, patients will be treated with two 14-day cycles of the CAPOX（Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt; D1-D14, capecitabine, 850-1000mg / m2, BID, PO）regimen. Two CAOPX regimens were treated one week apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: TislelizumabThe enrolled patients will receive a long course of NCRT (50 Gy / 25f, capecitabine 850-1000 mg / m2, BID, PO, D1-D5, QW) within the first 5 weeks. In regard to tumor immunotherapy, enrolled patients will receive tislelizumab (200 mg, iv) on the first day at week 2,5, and 8 after initiation of radiotherapy. Thereafter, patients will be treated with two 14-day cycles of the CAPOX（Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt; D1-D14, capecitabine, 850-1000mg / m2, BID, PO）regimen. Two CAOPX regimens were treated one week apart. Eight to 8-10 weeks after the completion of radiation therapy, patients will undergo multiple examinations, including colonoscopy and MRI. Subsequent treatment options will be determined by each center physician based on their clinical experience. |
| Control group | No intervention | –This group required only 5 weeks of NCRT and two 14-day cycles of the CAPOX （Q 3 w; D1 oxaliplatin, 130mg/m2,iv.gtt; D1-D14, capecitabine, 850-1000mg / m2, BID, PO）regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed a written informed consent form and volunteered to join the study;
- .Age: 18-75 years old, male or female;
- Pathohistologically confirmed rectal adenocarcinoma, along with immunohistochemical results of pMMR or genetic test results of MSS;
- The baseline clinical stage assessed by MRI was T1-2N1-2M0 or T3N0-2M0, MRF (-), lateral lymph nodes (-);
- The lower tumor margin is 10cm away from the anal margin;
Key exclusion criteria (11 listed)
- Previous history of allergy to monoclonal antibodies, any component of tislelizumab,and capecitabine;
- Previously has received or is receiving any of the following treatments:
- A)Any tumor-specific surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc; B)Treatment with immunosuppressive drugs or systemic hormones within 2 weeks of first use (dose> 10mg / day prednisone or equivalent dose); inhaled or topical steroids and dose> 10mg / day prednisone or equivalent dose of adrenocorticoid replacement in the absence of active autoimmune disease; C)Having received a live attenuated vaccine within 4 weeks before the first use of the study drug; D)Major surgery or severe trauma within 4 weeks before the first use of study drug;
- History of any active autoimmune or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered after hormone replacement therapy); patients with psoriasis or asthma / allergy in childhood and adults without any intervention, but patients requiring medical intervention with bronchodilators should not be included;
- A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;
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 |
|---|---|---|
| TislelizumabEnrolled patients will receive tislelizumab 3 times after initiation of radiotherapy. | Drug | Experimental group |
Primary outcome
CR
Time frame: pCR :within 10 days after surgery;cCR :13 weeks after radiotherapy begins
complete response rate=(number of pathological complete responses + number of clinical complete responses)/total number of patients
5 secondary outcomes
AE rate
Time frame: during treatment
NAR score
Time frame: within 10 days after surgery
ORR
Time frame: within 10 days after surgery
OPR
Time frame: immediately after surgery
immune-related adverse event rate
Time frame: up to 3 weeks after using tislelizumab
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 13 Jan 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.
2 sites 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 Tislelizumab in people with Locally Advanced Rectal Carcinoma, run by Beijing Friendship Hospital at 2 sites 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 11 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 13 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 2 sites 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?
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 Zhongtao Zhang, MD (+86 13801060364, Zhangzht@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR (time frame: pCR :within 10 days after surgery;cCR :13 weeks after radiotherapy begins). 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 13 Jan 2026.