CRC (Colorectal Cancer)Phase 2MA-CRC-II-018NCT07478731
Neoadjuvant SHR-1701 Plus Chemoradiotherapy for Locally Advanced Rectal Cancer
A Phase 2 study testing SHR-1701 neoadjuvant in people with CRC (Colorectal Cancer), run by Hong Qiu at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if SHR-1701 combine with chemoradiotherapy works to treat severe CRC. Participants will take: Induction: SHR-1701 combined with CAPOX for one cycle. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CRC (Colorectal Cancer)
- What is being tested?
- SHR-1701 neoadjuvant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2025to 31 Dec 2027
- 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
- 1: Sign the informed consent form and voluntarily participate in this study
- 2: Age 18-75
- 3: Pathologically confirmed rectal adenocarcinoma（At least meet any of the following criteria：cT3-4、cN2、EMVI+、MRF+）
- 4: pMMR or MSS/MSI-L rectal adenocarcinoma
- 5: The distance from tumor edge to the anal verge
- 6: Expect to complete R0 resection
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- 7: Patients can swallow pills
- 8: ECOG PS 0-1
- 9: Patients has not received any anti-tumor treatment before, including surgery, radiotherapy, chemotherapy, targeting therapy and immunotherapy
- 10: Plan to complete surgery after neoadjuvant therapy
- 11: There is contraindication to surgery
- 12: Main organ function efficient, including blood routine examination, blood biochemical examination, coagulation function
- 13: Female subjects with reproductive capacity are required to undergo a serum pregnancy test 72 hours before starting the administration of the test drug, and the result must be negative. During the trial period and for at least 3 months after the last administration, they must take effective contraceptive measures (such as intrauterine devices, contraceptives, or condoms). For male subjects whose partners are female with reproductive capacity, effective contraceptive measures must be taken during the trial period and for at least 3 months after the last administration.
Who cannot join
- Allergy to monoclonal antibody, SHR-1701, capecitabine, oxaliplatin and other platinum drugs
- The patient previously received or is receiving any following treatments: a) Any surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc; b) Within 2 weeks before the first use of the study drug, is using immunosuppressive drugs or systemic hormone drugs to achieve immunosuppression (dose > 10mg/day prednisone or equivalent); in the absence of active autoimmune diseases, inhalation or local use of steroids and doses > 10mg/day prednisone or equivalent adrenal cortical hormones are allowed; c) Has received attenuated live vaccines within 4 weeks before the first use of the study drug; d) Has undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the study drug.
- Having any active autoimmune disease or a history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered for inclusion after hormone replacement therapy); patients with psoriasis or childhood asthma/allergy that has completely resolved and does not require any intervention after adulthood can be considered for inclusion, but patients who require medical intervention with bronchodilators cannot be included.
- Have a history of immunodeficiency, including a positive HIV test result, or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation.
- There are heart diseases or clinical symptoms that are not well controlled, including but not limited to: (1) NYHA grade II or above heart failure, (2) unstable angina pectoris, (3) having experienced myocardial infarction within the past year, (4) having clinically significant supraventricular or ventricular arrhythmias that have not been controlled through clinical intervention or remain poorly controlled even after clinical intervention.
- Within 4 weeks prior to the first use of the study drug, there was a severe infection (CTCAE > grade 2), such as severe pneumonia, bacteremia, infection complications, etc required hospitalization; those with baseline chest imaging indicating active pulmonary inflammation, those who had symptoms and signs of infection or required oral or intravenous antibiotic treatment within 14 days prior to the first use of the study drug, excluding cases where antibiotics were used prophylactically.
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- Those who were found to have active tuberculosis infection through medical history or CT examination, or those who had a history of active tuberculosis infection within the previous 1 year of enrollment, or those who had a history of active tuberculosis infection more than 1 year ago but did not receive proper treatment.
- There is active hepatitis B (with HBVDNA ≥ 2000 IU/mL or 104 copies/mL) and hepatitis C (with positive hepatitis C antibody and HCVRNA above the detection limit of the analytical method)
- If within the 5 years prior to the first use of the investigational drug, one has been diagnosed with any other malignant tumor, except for those with low risk of metastasis or mortality (with a 5-year survival rate > 90%), such as fully treated skin basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ, etc., they may be considered for inclusion.
- Pregnant or lactating women
- Based on the researchers' assessment, there are other factors that could potentially lead to the premature termination of the study. These include having other serious illnesses (including mental disorders) that require combined treatment, alcohol abuse, drug abuse, family or social factors, which may affect the safety or compliance of the participants.
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
Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Hong Qiu, Doctor, ＋8613986296106, qiuhong@hust.edu.cn
About this study
Official title: A Phase II, Prospective, Single Arm Study of Neoadjuvant SHR-1701 Combine With Chemoradiotherapy for Locally Advanced Rectal Cancer
The goal of this clinical trial is to learn if SHR-1701 combine with chemoradiotherapy works to treat severe CRC.
Participants will take:
Induction: SHR-1701 combined with CAPOX for one cycle. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: SHR-1701 combined with CAPOX for five cycles, after which the subjects undergo TME surgery.
Read the detailed description
- Induction Phase SHR-1701: Intravenous infusion at a fixed dose of 30 mg/kg, depending on the protocol), administered on Day 1. CAPOX Regimen: Oxaliplatin: 130 mg/m², intravenous infusion on Day 1; Capecitabine: 1000 mg/m², orally twice daily from Day 1 to Day 14, followed by 7 days of rest. This phase consists of 1 cycle (each cycle is 21 days).
- Radiotherapy Short-course radiotherapy (SCRT) will be initiated shortly after the induction phase: Total dose: 25 Gy delivered in 5 fractions of 5 Gy each, administered on 5 consecutive days .
- Consolidation Phase Following radiotherapy, participants will continue treatment with SHR-1701 combined with CAPOX: SHR-1701: Same dose as induction, administered every 3 weeks (Day 1 of each cycle). CAPOX: Same regimen as induction, administered every 3 weeks. This phase consists of 5 cycles (each cycle is 21 days).
- Surgery After completion of the consolidation phase, total mesorectal excision (TME) will be performed based on investigator assessment and surgical indications.
Surgery is typically scheduled within 4 to 8 weeks after completion of consolidation therapy to allow adequate tumor regression and patient recovery.
- Conditions
- CRC (Colorectal Cancer)
- Being tested
- SHR-1701 neoadjuvant
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701 neoadjuvantDrug
Induction: SHR-1701 combined with CAPOX for one cycle. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: SHR-1701 combined with CAPOX for five cycles, after which the subjects undergo TME surgery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Drug: SHR-1701 neoadjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
No residual viable tumor cells in either the primary tumor site or the lymph nodes
Measured: At surgery (pathological assessment)
Secondary outcomes (2)
cCR
no evidence of any residual tumor was detected in the primary tumor site and regional lymph nodes
Measured: At completion of neoadjuvant therapy (prior to surgery)
OS
Time from enrollment to death
Measured: From date of randomization until date of death due to any cause, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start20 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRC (Colorectal Cancer)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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Qiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hong Qiu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478731
- Sponsor's protocol ID
- MA-CRC-II-018
- Acronym
- MA-CRC-II-018
- Status last verified
- Feb 2026
- First submitted
- 12 Dec 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Prospective, Single Arm Study of Neoadjuvant SHR-1701 Combine With Chemoradiotherapy for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07478731
- Acronym / sponsor ID
- MA-CRC-II-018 / MA-CRC-II-018
- Conditions
- CRC (Colorectal Cancer)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hong QiuUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Mar 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.
The goal of this clinical trial is to learn if SHR-1701 combine with chemoradiotherapy works to treat severe CRC.
Participants will take:
Induction: SHR-1701 combined with CAPOX for one cycle. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: SHR-1701 combined with CAPOX for five cycles, after which the subjects undergo TME surgery.
Detailed description
- Induction Phase SHR-1701: Intravenous infusion at a fixed dose of 30 mg/kg, depending on the protocol), administered on Day 1. CAPOX Regimen: Oxaliplatin: 130 mg/m², intravenous infusion on Day 1; Capecitabine: 1000 mg/m², orally twice daily from Day 1 to Day 14, followed by 7 days of rest. This phase consists of 1 cycle (each cycle is 21 days).
- Radiotherapy Short-course radiotherapy (SCRT) will be initiated shortly after the induction phase: Total dose: 25 Gy delivered in 5 fractions of 5 Gy each, administered on 5 consecutive days .
- Consolidation Phase Following radiotherapy, participants will continue treatment with SHR-1701 combined with CAPOX: SHR-1701: Same dose as induction, administered every 3 weeks (Day 1 of each cycle). CAPOX: Same regimen as induction, administered every 3 weeks. This phase consists of 5 cycles (each cycle is 21 days).
- Surgery After completion of the consolidation phase, total mesorectal excision (TME) will be performed based on investigator assessment and surgical indications.
Surgery is typically scheduled within 4 to 8 weeks after completion of consolidation therapy to allow adequate tumor regression and patient recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: SHR-1701 neoadjuvant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1: Sign the informed consent form and voluntarily participate in this study
- 2: Age 18-75
- 3: Pathologically confirmed rectal adenocarcinoma（At least meet any of the following criteria：cT3-4、cN2、EMVI+、MRF+）
- 4: pMMR or MSS/MSI-L rectal adenocarcinoma
- 5: The distance from tumor edge to the anal verge
Key exclusion criteria (11 listed)
- Allergy to monoclonal antibody, SHR-1701, capecitabine, oxaliplatin and other platinum drugs
- The patient previously received or is receiving any following treatments: a) Any surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc; b) Within 2 weeks before the first use of the study drug, is using immunosuppressive drugs or systemic hormone drugs to achieve immunosuppression (dose > 10mg/day prednisone or equivalent); in the absence of active autoimmune diseases, inhalation or local use of steroids and doses > 10mg/day prednisone or equivalent adrenal cortical hormones are allowed; c) Has received attenuated live vaccines within 4 weeks before the first use of the study drug; d) Has undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the study drug.
- Having any active autoimmune disease or a history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered for inclusion after hormone replacement therapy); patients with psoriasis or childhood asthma/allergy that has completely resolved and does not require any intervention after adulthood can be considered for inclusion, but patients who require medical intervention with bronchodilators cannot be included.
- Have a history of immunodeficiency, including a positive HIV test result, or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation.
- There are heart diseases or clinical symptoms that are not well controlled, including but not limited to: (1) NYHA grade II or above heart failure, (2) unstable angina pectoris, (3) having experienced myocardial infarction within the past year, (4) having clinically significant supraventricular or ventricular arrhythmias that have not been controlled through clinical intervention or remain poorly controlled even after clinical intervention.
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 |
|---|---|---|
| SHR-1701 neoadjuvantInduction: SHR-1701 combined with CAPOX for one cycle. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: SHR-1701 combined with CAPOX for five cycles, after which the subjects undergo TME surgery. | Drug | Treatment Arm |
Primary outcome
pCR
Time frame: At surgery (pathological assessment)
No residual viable tumor cells in either the primary tumor site or the lymph nodes
2 secondary outcomes
cCR
Time frame: At completion of neoadjuvant therapy (prior to surgery)
OS
Time frame: From date of randomization until date of death due to any cause, assessed up to 2 years
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 17 Mar 2026.
- Individual participant dataSharing planned: Yes
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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 SHR-1701 neoadjuvant in people with CRC (Colorectal Cancer), run by Hong Qiu 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 13 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 17 Mar 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 Qiu Hong (027 8366 2688, qiuhong@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: At surgery (pathological assessment)). 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 17 Mar 2026.