Colorectal CancerPhase 2NCT07515820
SHR-3821 in Advanced Colorectal Cancer: an Exploratory Study
A Phase 2 study testing SHR-3821 and fruquintinib in people with Colorectal Cancer, run by Meng Qiu.
Trial summary
To evaluate the safety and efficacy of SHR-3821 combined with fruquintinib in the advanced colorectal cancer after failure of standard therapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- SHR-3821 and fruquintinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2026to 28 Apr 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
- Histologically or cytologically confirmed unresectable recurrent or metastatic colorectal cancer.
- Aged 18-75 years, male or female.
- Failure of ≥2 lines of prior standard systemic therapy, which should have included oxaliplatin, irinotecan, and fluoropyrimidine-based chemotherapy. Subjects who failed first-line therapy are eligible if the first-line regimen contained all three chemotherapeutic agents, or if they exhibited intolerance or lack of response to oxaliplatin during adjuvant therapy. Subjects with dMMR/MSI-H tumors must also have failed anti-PD-1/PD-L1 antibody therapy.
- Life expectancy ≥3 months.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
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- Adequate organ and bone marrow function within 7 days prior to the first dose, as defined below:
- Hematology (without transfusion or growth factor support within 14 days): hemoglobin ≥90 g/L; platelet count ≥100×10^9/L; white blood cell count ≥3.5×10^9/L; absolute neutrophil count ≥1.5×10^9/L.
- Liver function: total bilirubin ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase and alanine aminotransferase ≤2.5 × ULN (≤5 × ULN if liver metastases are present).
- Renal function: serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥60 mL/min (using the Cockcroft-Gault formula).
- Coagulation: international normalized ratio ≤1.5 × ULN (or between 2.0 and 3.0 if on stable warfarin therapy); activated partial thromboplastin time and prothrombin time ≤1.5 × ULN.
- Male patients and female patients of childbearing potential must use highly effective contraception during the study and for 12 months after the last dose. Female patients must be non-lactating and have a negative serum pregnancy test within 7 days before the first dose.
- Voluntary participation, signed informed consent, good compliance, and willingness to cooperate with follow-up.
Who cannot join
- Presence of concurrent active malignancies other than the primary tumor (except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder cancer, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and gastrointestinal tumors confirmed cured by endoscopic mucosal resection). History of prior malignancy is allowed if the disease has been cured for ≥2 years.
- Patients with untreated or active central nervous system (CNS) metastases or leptomeningeal metastasis. Patients are eligible if they have received local therapy, have stable neurological symptoms for at least 2 weeks prior to the first dose, and do not require corticosteroids or require ≤10 mg/day of prednisone (or equivalent).
- Presence of severe complications at the primary site (e.g., perforation, obstruction, uncontrollable massive hemorrhage).
- Uncontrolled or moderate-to-large pleural effusion or pericardial effusion. Clinically symptomatic moderate or severe ascites (patients with small ascites detected only by imaging without clinical symptoms are eligible).
- Toxicities and/or complications from prior interventions have not recovered to ≤ Grade 1 per NCI CTCAE or to levels specified in the inclusion/exclusion criteria (except for toxicities judged by the investigator as safe and controllable, such as alopecia, ≤ Grade 2 peripheral neuropathy).
- Uncontrolled hypertension or history of hypertensive crisis.
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- Significant cardiovascular or cerebrovascular diseases, including but not limited to:
- Left ventricular ejection fraction (LVEF) <50% within 28 days prior to the first dose.
- Severe cardiac arrhythmia or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, grade ii-iii atrioventricular block.
- Acute coronary syndrome, congestive heart failure (new york heart association (NYHA) class ≥II), aortic dissection, stroke, or other grade 3 or higher cardiovascular/cerebrovascular events within 6 months prior to the first dose.
- Average QTc interval ≥450 ms for males and ≥470 ms for females based on two electrocardiogram (ECG) measurements (QTcF=QT/RR^0.33).
- Arterial/venous thrombotic events, such as cerebrovascular accident, deep vein thrombosis, or pulmonary embolism, within 6 months prior to the first dose.
- Major surgery (defined as surgery requiring general anesthesia and a recovery period of at least 3 weeks) within 28 days prior to the first dose of study drug (diagnostic biopsy is allowed).
- Active tuberculosis or history of active tuberculosis infection within ≤48 weeks prior to screening, regardless of treatment.
- History of interstitial lung disease (ILD), or radiographic findings suggestive of or cannot rule out ild at screening; or other moderate-to-severe pulmonary diseases that significantly impair lung function.
- Active hepatitis b or active hepatitis c (HBV DNA≥1x10^3).
- History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- Severe infection within 4 weeks prior to the first dose, including but not limited to bacteremia or severe pneumonia requiring hospitalization; or active infection of CTCAE grade ≥2 requiring systemic antibiotic therapy within 2 weeks prior to the first dose.
- Any significant clinical or laboratory abnormality that, in the investigator's judgment, may affect safety evaluation (e.g., uncontrolled diabetes, chronic kidney disease, thyroid dysfunction, poorly controlled hypercholesterolemia).
- Known history of hypersensitivity to any component of the investigational agents.
- Inability to swallow study drugs, or conditions affecting drug administration and absorption (e.g., chronic diarrhea [including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis], intestinal obstruction).
- Pregnant or lactating women, or patients of childbearing potential (men or women with less than 1 year since last menstruation) unwilling to use effective contraception.
- Any other condition that, in the investigator's judgment, may increase the risk associated with study participation, interfere with the interpretation of study results, or make the patient unsuitable for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To evaluate the safety and efficacy of SHR-3821 combined with fruquintinib in the advanced colorectal cancer after failure of standard therapy
Read the detailed description
This is a single-center, open-label, exploratory phase II clinical trial designed to investigate the efficacy and safety of SHR-3821 in combination with fruquintinib for the treatment of metastatic colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- SHR-3821 and fruquintinib
- Keywords
- SHR-3821, Colorectal cancer
- 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-3821 and fruquintinibDrug
SHR-3821, administered by intravenous infusion Fruquintinib, administered orally
| Study group | Role | What they receive |
|---|---|---|
| SHR-3821 combined with fruquintinib | Experimental | Not described Receives: Drug: SHR-3821 and fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment related adverse event [Safety and Tolerability]
To identify the incidence of adverse events (AEs) and severe adverse events (SAEs) in clinical trial
Measured: From the initiation of the first dose to 90 days after the last dose
Objective response rate (ORR)
To evaluate the efficacy of anti-tumor
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (4)
Duration of Response (DOR)
To evaluate the efficacy of anti-tumor
Measured: From enrollment to the end of treatment at 6 weeks
Disease control rate (DCR)
To evaluate the efficacy of anti-tumor
Measured: From enrollment to the end of treatment at 6 weeks
Progression-free survival (PFS)
To evaluate the efficacy of anti-tumor
Measured: From enrollment to the end of treatment at 12 weeks
Overall survival (OS)
To evaluate the efficacy of anti-tumor
Measured: From enrollment to the end of treatment at 12 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start27 Apr 2026 (estimated)
- Primary completion28 Jul 2027 (estimated)
- Study completion28 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meng Qiu
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Meng Qiu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515820
- Sponsor's protocol ID
- CRC-MUL-IIT-SHR3821
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHR-3821 in Advanced Colorectal Cancer: an Exploratory Study
- ClinicalTrials.gov ID
- NCT07515820
- Acronym / sponsor ID
- CRC-MUL-IIT-SHR3821
- Conditions
- Colorectal Cancer
- Keywords
- SHR-3821, Colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Meng QiuUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 27 Apr 2026 (estimated)
- Primary completion
- 28 Jul 2027 (estimated)
- Study completion
- 28 Apr 2028 (estimated)
- First posted
- 7 Apr 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 safety and efficacy of SHR-3821 combined with fruquintinib in the advanced colorectal cancer after failure of standard therapy
Detailed description
This is a single-center, open-label, exploratory phase II clinical trial designed to investigate the efficacy and safety of SHR-3821 in combination with fruquintinib for the treatment of metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-3821 combined with fruquintinib | Experimental | Drug: SHR-3821 and fruquintinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically confirmed unresectable recurrent or metastatic colorectal cancer.
- Aged 18-75 years, male or female.
- Failure of ≥2 lines of prior standard systemic therapy, which should have included oxaliplatin, irinotecan, and fluoropyrimidine-based chemotherapy. Subjects who failed first-line therapy are eligible if the first-line regimen contained all three chemotherapeutic agents, or if they exhibited intolerance or lack of response to oxaliplatin during adjuvant therapy. Subjects with dMMR/MSI-H tumors must also have failed anti-PD-1/PD-L1 antibody therapy.
- Life expectancy ≥3 months.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1.
Key exclusion criteria (23 listed)
- Presence of concurrent active malignancies other than the primary tumor (except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder cancer, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and gastrointestinal tumors confirmed cured by endoscopic mucosal resection). History of prior malignancy is allowed if the disease has been cured for ≥2 years.
- Patients with untreated or active central nervous system (CNS) metastases or leptomeningeal metastasis. Patients are eligible if they have received local therapy, have stable neurological symptoms for at least 2 weeks prior to the first dose, and do not require corticosteroids or require ≤10 mg/day of prednisone (or equivalent).
- Presence of severe complications at the primary site (e.g., perforation, obstruction, uncontrollable massive hemorrhage).
- Uncontrolled or moderate-to-large pleural effusion or pericardial effusion. Clinically symptomatic moderate or severe ascites (patients with small ascites detected only by imaging without clinical symptoms are eligible).
- Toxicities and/or complications from prior interventions have not recovered to ≤ Grade 1 per NCI CTCAE or to levels specified in the inclusion/exclusion criteria (except for toxicities judged by the investigator as safe and controllable, such as alopecia, ≤ Grade 2 peripheral neuropathy).
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-3821 and fruquintinibSHR-3821, administered by intravenous infusion Fruquintinib, administered orally | Drug | SHR-3821 combined with fruquintinib |
Primary outcome
Incidence of treatment related adverse event [Safety and Tolerability]
Time frame: From the initiation of the first dose to 90 days after the last dose
To identify the incidence of adverse events (AEs) and severe adverse events (SAEs) in clinical trial
Objective response rate (ORR)
Time frame: From enrollment to the end of treatment at 6 weeks
To evaluate the efficacy of anti-tumor
4 secondary outcomes
Duration of Response (DOR)
Time frame: From enrollment to the end of treatment at 6 weeks
Disease control rate (DCR)
Time frame: From enrollment to the end of treatment at 6 weeks
Progression-free survival (PFS)
Time frame: From enrollment to the end of treatment at 12 weeks
Overall survival (OS)
Time frame: From enrollment to the end of treatment at 12 moths
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 7 Apr 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-3821 and fruquintinib in people with Colorectal Cancer, run by Meng Qiu.
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 23 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yuwen Zhou (15328007741, drzhouyuwen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment related adverse event [Safety and Tolerability] (time frame: From the initiation of the first dose to 90 days after the last dose). The study lists 2 primary outcomes in all. 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 7 Apr 2026.