Rectal Neoplasms MalignantPhase 2NCT07383285
CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab as First-line Treatment for RAS-Mutant/MSS Metastatic Rectal Cancer
A Phase 2 study testing Iparomlimab and Tuvonralimab, Radiotherapy to the primary site and Capecitabine in people with Rectal Neoplasms Malignant, run by Peking University Cancer Hospital & Institute.
Trial summary
Research objective: To compare the efficacy and safety of Capox + Bev versus Capox + Bev combined with primary site radiotherapy + (Iparomlimab and Tuvonralimab) as the first-line treatment for RAS Mutation/pMMR metastatic rectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasms Malignant
- What is being tested?
- Iparomlimab and Tuvonralimab, Radiotherapy to the primary site and Capecitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Dec 2029
- 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
- The subjects were able to understand the informed consent form, voluntarily participated and signed the informed consent form;
- On the day of signing the informed consent form, the subjects were aged between 18 and 75 years old, regardless of gender;
- Pathological tissue diagnosis confirmed rectal adenocarcinoma (including signet ring cell carcinoma and mucinous adenocarcinoma);
- The lower boundary of the lesion was within 15 cm from the anal verge;
- The clinical stage was stage IV;
- The genetic test results were KRAS or NRAS mutations, without BRAF V600 mutations, and the immunohistochemical results were pMMR;
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- The subjects had not received palliative drug treatment, or had received 1 cycle of FOLFOX/CAPOX and had not undergone tumor efficacy assessment;
- According to the RECIST 1.1 standard, there was at least 1 measurable lesion or assessable lesion at the baseline;
- The primary lesion existed and had not undergone radiotherapy previously;
- The ECOG score was 0 or 1 (Appendix 4);
- The expected survival period was ≥ 6 months;
- Female subjects with fertility or male subjects whose partner had fertility agreed to adopt effective contraceptive measures starting from 7 days before the first administration until 120 days after the last administration (refer to Appendix 3);
- The subjects were capable and willing to comply with the visit, treatment plan, laboratory tests and other research-related procedures stipulated in the research protocol;
- Within 7 days before the first administration, they had good organ function
Who cannot join
- Subjects with untreated active brain metastases or meningeal metastases; if the brain metastases of the subject have been treated and the condition of the metastases is stable (brain imaging examination at least 4 weeks before the first administration shows stable lesions, and there are no new neurological symptoms or the neurological symptoms have recovered to baseline levels), and there is no evidence of new onset or enlargement of the metastases, they are allowed to be enrolled; (2) Have the following cardiovascular conditions:
- Active coronary heart disease with angina pectoris or patients who need to take medication to prevent angina attacks;
- NYHA II-IV grade chronic heart failure;
- Uncontrolled hypertension after drug treatment (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
- Major vascular diseases (such as aortic aneurysm, aortic dissection aneurysm, internal carotid artery stenosis);
- Has had thromboembolic or cerebrovascular embolic events within 6 months. (3) Have the following digestive system diseases:
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- 1) Within 6 months, there has been abdominal fistula, gastrointestinal perforation or abdominal abscess or active gastrointestinal bleeding. If the perforation or fistula has been treated by resection or repair, and the disease has been judged by the investigator to have recovered or alleviated, it is allowed to be enrolled; 2) Have gastric, duodenal ulcers or ulcer malignancy, intestinal obstruction/obstruction with incomplete obstruction; 3) Have chronic enteritis and/or inflammatory bowel disease; (4) Have abnormal coagulation conditions:
- Have bleeding (including hemoptysis) or coagulation disorders;
- Are taking warfarin, aspirin (except for small doses of less than 100 mg per day), low molecular weight heparin and other antiplatelet aggregation Chinese and Western drugs.
- Within 28 days before the first administration or 5 half-lives (whichever is shorter, but at least 2 weeks) have received any other interventional clinical trials or received other anti-tumor treatment for the purpose of alleviating symptoms of bone metastases is allowed; (6) Within 28 days before the first administration have received major surgical treatment (such as major surgeries through the abdomen or thorax; excluding drainage, diagnostic punctures or peripheral vascular access replacement surgeries); (7) Within 14 days before the first administration need to receive continuous 7 days of systemic corticosteroid treatment (≥ 10 mg/day prednisone, or equivalent other corticosteroids) or immunosuppressant treatment; except for inhalation or local application of corticosteroids, or receiving physiological replacement doses of corticosteroids due to adrenal insufficiency; allowed for short-term (≤ 7 days) corticosteroids for prevention (for example, contrast agent allergy) or treatment of non-autoimmune diseases (for example, delayed-type hypersensitivity reaction caused by exposure to allergens); (8) Within 28 days before the first administration have received live vaccines (including attenuated live vaccines); (9) Have interstitial lung disease, or have a history of non-infectious pneumonia requiring oral or intravenous administration of glucocorticoids; (10) Within 2 years before the start of the study treatment need systemic treatment for active autoimmune diseases, or the investigator judges that there is a possibility of recurrence or planned treatment for autoimmune diseases. The following are excluded: a) Skin diseases that do not require systemic treatment (such as: vitiligo, alopecia, psoriasis or eczema); b) Hypothyroidism caused by autoimmune thyroiditis, only requiring stable doses of hormone replacement therapy; c) Type I diabetes that only requires stable doses of insulin replacement therapy; d) Childhood asthma has completely resolved, and no intervention is needed after adulthood; e) The investigator judges that the disease will not recur without external triggering factors. (11) Within 5 years prior to the first administration, having another malignant tumor, except for cured skin squamous cell carcinoma, basal cell carcinoma, non-invasive bladder cancer, localized low-risk prostate cancer (defined as stage ≤ T2a, Gleason score ≤ 6, and PSA ≤ 10 ng/mL at the time of prostate cancer diagnosis (if measured), patients who have received radical treatment and have no biochemical recurrence of prostate-specific antigen (PSA)), and in situ cervical/breast cancer; (12) Having uncontrolled comorbidities, including but not limited to the following conditions: a) Active HBV or HCV infection; b) Subjects with positive HBsAg and/or HCV antibody during the screening period, must undergo HBV DNA and/or HCV RNA testing. Subjects with HBV DNA ≤ 500 IU/mL (or ≤ 2000 copies/mL) and/or negative HCV RNA can be enrolled; during the trial, the study investigator decides to monitor HBV DNA based on the subject's condition; c) Known HIV infection or AIDS history; d) Active tuberculosis; e) Active infection or systemic use of anti-infective drugs for more than 1 week before the first administration of this study and within 28 days before the first administration; fever of unknown origin occurred within 2 weeks before administration; f) Uncontrolled hypertension (resting blood pressure ≥ 160/100 mmHg), symptomatic heart dysfunction (NYHA II-IV), unstable angina pectoris or myocardial infarction within 6 months, or QTc prolongation or risk of arrhythmia (baseline QTc > 470 msec corrected by Fridericia method, refractory hypokalemia, long QT syndrome, resting heart rate > 100 bpm atrial fibrillation or severe valvular heart disease); g) Active bleeding that cannot be controlled by medical treatment; (13) Toxicity from previous anti-tumor therapy has not recovered to CTCAE ≤ 1 grade (NCI-CTCAE v5.0) or baseline level, except alopecia, skin pigmentation (allowing any grade), and immune-related adverse reactions that require physiological dose substitution (such as hypothyroidism, pituitary insufficiency, type I diabetes, etc.); (14) Previous history of allogeneic bone marrow or organ transplantation; (15) Previous history of allergic reactions to antibody drugs, hypersensitivity reactions, or intolerance (such as severe allergic reactions, immune-mediated liver toxicity, immune-mediated thrombocytopenia or anemia); (16) Pregnant and/or lactating women; (17) Other situations that the investigator considers to affect the safety or compliance of the treatment with the study drug, including but not limited to moderate to large pleural/abdominal effusion/pericardial effusion, refractory pleural/abdominal effusion/pericardial effusion, intestinal obstruction or subacute intestinal obstruction, mental disorders, etc.; (18) Previous treatment with immune checkpoint blockers or T-cell co-stimulation drugs, including but not limited to immune checkpoint blockers such as PD-1, PD-L1, CTLA4, LAG3, etc., therapeutic vaccines, etc.
About this study
Official title: CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab as First-line Treatment for RAS-Mutant/MSS Metastatic Rectal Cancer: An Open-label, Randomized, Multi-center Phase II Study
Research objective: To compare the efficacy and safety of Capox + Bev versus Capox + Bev combined with primary site radiotherapy + (Iparomlimab and Tuvonralimab) as the first-line treatment for RAS Mutation/pMMR metastatic rectal cancer patients.
Study endpoint:
Read more
Primary endpoint: 12-month progression-free survival rate (PFSR)
Secondary endpoints:
- The objective response rate (ORR) and disease control rate (DCR) as determined by the investigator according to the RECIST 1.1 standard, time to response (TTR), duration of response (DOR), progression-free survival (PFS), 6-month progression-free survival rate (PFSR), overall survival (OS);
- The frequency and severity of adverse events (AEs) during treatment (NCI CTCAE 5.0).
This study will enroll 106 patients (stratification factors: presence or absence of liver metastasis; whether NED could be achieved). They were randomly assigned in a 1:1 ratio to:
The treatment group: Capox + Bev combined with primary site radiotherapy and (Iparomlimab and Tuvonralimab), administered every 3 weeks (Q3w), up to a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev + (Iparomlimab and Tuvonralimab), administered every 3 weeks (Q3w).
The control group: Capox + Bev, administered every 3 weeks (Q3w), up to a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev, administered every 3 weeks (Q3w).
Read the detailed description
This study is an open-label, randomized controlled, multicenter phase II clinical trial, aiming to evaluate the efficacy and safety of the Capox + Bev combination (with or without concurrent primary lesion radiotherapy + (Iparomlimab and Tuvonralimab) as the first-line treatment for patients with RAS mutation/pMMR metastatic rectal cancer.
This study will enroll 106 patients, (stratification factors: presence or absence of liver metastasis; whether NED could be achieved) and was randomly assigned in a 1:1 ratio to:
The treatment group: Capox + Bev combined with primary lesion radiotherapy and (Iparomlimab and Tuvonralimab), administered once every 3 weeks (Q3w), for a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev + (Iparomlimab and Tuvonralimab), administered once every 3 weeks (Q3w).
The control group: Capox + Bev, administered once every 3 weeks (Q3w), for a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev, administered once every 3 weeks (Q3w).
Treatment plan The experimental group will receive Capox + Bev combined with primary lesion radiotherapy and (Iparomlimab and Tuvonralimab): Oxaliplatin 130mg/m2 on day 1, Capecitabine 1000mg/m2 twice daily from day 1 to day 14, Bevacizumab 7.5mg/kg on day 1, (Iparomlimab and Tuvonralimab) 5mg/kg on day 1, repeated every 3 weeks, up to a maximum of 8 cycles. On the third cycle, primary lesion radiotherapy is conducted simultaneously, with the specific range and dose of 95% PGTV (rectal primary lesion) 25Gy/5 fractions [Before and after radiotherapy, the chemotherapy and Bevacizumab can be adjusted (stopped or reduced) according to the specific patient's adverse reactions]. Then enter the Capecitabine + Bev + (Iparomlimab and Tuvonralimab) maintenance treatment: Capecitabine 1000mg/m2 twice daily from day 1 to day 14, Bevacizumab 7.5mg/kg on day 1, (Iparomlimab and Tuvonralimab) 5mg/kg on day 1, repeated every 3 weeks. Until disease progression, occurrence of intolerable toxicity, acceptance of new anti-tumor treatment, withdrawal of informed consent, loss to follow-up, death, or other researchers determine that treatment should be stopped, whichever occurs first. If during the treatment process, one drug is discontinued for any reason, other drugs can continue to be used.
The control group will receive Capox + Bev: Oxaliplatin 130mg/m2 on day 1, Capecitabine 1000mg/m2 twice daily from day 1 to day 14, Bevacizumab 7.5mg/kg on day 1, repeated every 3 weeks, up to a maximum of 8 cycles. Then enter the Capecitabine + Bev maintenance treatment: Capecitabine 1000mg/m2 twice daily from day 1 to day 14, Bevacizumab 7.5mg/kg on day 1, repeated every 3 weeks. Until disease progression, occurrence of intolerable toxicity, acceptance of new anti-tumor treatment, withdrawal of informed consent, loss to follow-up, death, or other researchers determine that treatment should be stopped, whichever occurs first. If during the treatment process, one drug is discontinued for any reason, other drugs can continue to be used.
- Conditions
- Rectal Neoplasms Malignant
- Being tested
- Iparomlimab and Tuvonralimab, Radiotherapy to the primary site, Capecitabine, Bevacizumab, Oxaliplatin injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and TuvonralimabDrug
Also called QL1706
(Experimental group) PD-1/CTLA-4 Antibody
Radiotherapy to the primary siteRadiation
(Experimental group) Radiotherapy to the primary site of rectal
CapecitabineDrug
(both groups)
BevacizumabDrug
(both groups)
Oxaliplatin injectionDrug
(both groups)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group: Capox + Bev combined with primary lesion radiotherapy and (Iparomlimab and Tuvonralimab), administered once every 3 weeks (Q3w), for a maximum of 8 cycles. Then, it entered the maintenance treatment stage with Capecitabine + Bev + (Iparomlimab and Tuvonralimab), administered once every 3 weeks (Q3w). Receives: Drug: Iparomlimab and Tuvonralimab; Radiation: Radiotherapy to the primary site; Drug: Capecitabine; Drug: Bevacizumab; Drug: Oxaliplatin injection |
| Control group | Active comparator | Control group: Capox + Bev, administered once every 3 weeks (Q3w), for a maximum of 8 cycles. Then, it entered the maintenance treatment stage with Capecitabine + Bev, administered once every 3 weeks (Q3w). Receives: Drug: Capecitabine; Drug: Bevacizumab; Drug: Oxaliplatin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month disease-free survival rate (progression-free survival rate, PFSR)
Measured: From randomization to disease progression or death from any cause, whichever occurs first; the progression-free survival rate will be estimated at 12 months.
Secondary outcomes (7)
Objective response rate (ORR)
Measured: From randomization to the first documented tumor response, assessed during the entire treatment period and follow-up, up to 24 months.
Disease control rate (DCR)
Measured: From randomization to the first documented tumor response, assessed during the entire treatment period and follow-up, up to 24 months.
Time to response (TTR)
Measured: From randomization to the first documented objective response (complete or partial response), assessed up to 24 months.
Duration of response (DOR)
Measured: From the first documented objective response (CR or PR) to disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
6-month progression-free survival rate (PFSR)
Measured: From randomization to disease progression or death from any cause, whichever occurs first; the progression-free survival rate will be estimated at 6 months.
Progression-free survival (PFS)
Measured: From randomization to disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Overall survival (OS)
Measured: From randomization to death from any cause, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Neoplasms MalignantStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Medical University Fourth Hospital, Shanxi Province Cancer Hospital, West China Hospital, Peking Union Medical College Hospital
- Responsible party
- Principal investigator, Jian Li, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383285
- Sponsor's protocol ID
- NOVA-Rec01
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 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 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPOX and Bevacizumab With or Without Primary Tumor Radiotherapy and Iparomlimab and Tuvonralimab as First-line Treatment for RAS-Mutant/MSS Metastatic Rectal Cancer: An Open-label, Randomized, Multi-center Phase II Study
- ClinicalTrials.gov ID
- NCT07383285
- Acronym / sponsor ID
- NOVA-Rec01
- Conditions
- Rectal Neoplasms Malignant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Hebei Medical University Fourth Hospital, Shanxi Province Cancer Hospital, West China Hospital, Peking Union Medical College Hospital
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Feb 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.
Research objective: To compare the efficacy and safety of Capox + Bev versus Capox + Bev combined with primary site radiotherapy + (Iparomlimab and Tuvonralimab) as the first-line treatment for RAS Mutation/pMMR metastatic rectal cancer patients.
Study endpoint:
Primary endpoint: 12-month progression-free survival rate (PFSR)
Secondary endpoints:
- The objective response rate (ORR) and disease control rate (DCR) as determined by the investigator according to the RECIST 1.1 standard, time to response (TTR), duration of response (DOR), progression-free survival (PFS), 6-month progression-free survival rate (PFSR), overall survival (OS);
- The frequency and severity of adverse events (AEs) during treatment (NCI CTCAE 5.0).
This study will enroll 106 patients (stratification factors: presence or absence of liver metastasis; whether NED could be achieved). They were randomly assigned in a 1:1 ratio to:
The treatment group: Capox + Bev combined with primary site radiotherapy and (Iparomlimab and Tuvonralimab), administered every 3 weeks (Q3w), up to a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev + (Iparomlimab and Tuvonralimab), administered every 3 weeks (Q3w).
The control group: Capox + Bev, administered every 3 weeks (Q3w), up to a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev, administered every 3 weeks (Q3w).
Detailed description
This study is an open-label, randomized controlled, multicenter phase II clinical trial, aiming to evaluate the efficacy and safety of the Capox + Bev combination (with or without concurrent primary lesion radiotherapy + (Iparomlimab and Tuvonralimab) as the first-line treatment for patients with RAS mutation/pMMR metastatic rectal cancer.
This study will enroll 106 patients, (stratification factors: presence or absence of liver metastasis; whether NED could be achieved) and was randomly assigned in a 1:1 ratio to:
The treatment group: Capox + Bev combined with primary lesion radiotherapy and (Iparomlimab and Tuvonralimab), administered once every 3 weeks (Q3w), for a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev + (Iparomlimab and Tuvonralimab), administered once every 3 weeks (Q3w).
The control group: Capox + Bev, administered once every 3 weeks (Q3w), for a maximum of 8 cycles, followed by a maintenance treatment stage of Capecitabine + Bev, administered once every 3 weeks (Q3w).
Treatment plan The experimental group will receive Capox + Bev combined with primary lesion radiotherapy and (Iparomlimab and Tuvonralimab): Oxaliplatin 130mg/m2 on day 1, Capecitabine 1000mg/m2 twice daily from day 1 to day 14, Bevacizumab 7.5mg/kg on day 1, (Iparomlimab and Tuvonralimab) 5mg/kg on day 1, repeated every 3 weeks, up to a maximum of 8 cycles. On the third cycle, primary lesion radiotherapy is conducted simultaneously, with the specific range and dose of 95% PGTV (rectal primary lesion) 25Gy/5 fractions [Before and after radiotherapy, the chemotherapy and Bevacizumab can be adjusted (stopped or reduced) according to the specific patient's adverse reactions]. Then enter the Capecitabine + Bev + (Iparomlimab and Tuvonralimab) maintenance treatment: Capecitabine 1000mg/m2 twice daily from day 1 to day 14, Bevacizumab 7.5mg/kg on day 1, (Iparomlimab and Tuvonralimab) 5mg/kg on day 1, repeated every 3 weeks. Until disease progression, occurrence of intolerable toxicity, acceptance of new anti-tumor treatment, withdrawal of informed consent, loss to follow-up, death, or other researchers determine that treatment should be stopped, whichever occurs first. If during the treatment process, one drug is discontinued for any reason, other drugs can continue to be used.
The control group will receive Capox + Bev: Oxaliplatin 130mg/m2 on day 1, Capecitabine 1000mg/m2 twice daily from day 1 to day 14, Bevacizumab 7.5mg/kg on day 1, repeated every 3 weeks, up to a maximum of 8 cycles. Then enter the Capecitabine + Bev maintenance treatment: Capecitabine 1000mg/m2 twice daily from day 1 to day 14, Bevacizumab 7.5mg/kg on day 1, repeated every 3 weeks. Until disease progression, occurrence of intolerable toxicity, acceptance of new anti-tumor treatment, withdrawal of informed consent, loss to follow-up, death, or other researchers determine that treatment should be stopped, whichever occurs first. If during the treatment process, one drug is discontinued for any reason, other drugs can continue to be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Iparomlimab and Tuvonralimab, Radiation: Radiotherapy to the primary site, Drug: Capecitabine, Drug: Bevacizumab, Drug: Oxaliplatin injectionExperimental group: Capox + Bev combined with primary lesion radiotherapy and (Iparomlimab and Tuvonralimab), administered once every 3 weeks (Q3w), for a maximum of 8 cycles. Then, it entered the maintenance treatment stage with Capecitabine + Bev + (Iparomlimab and Tuvonralimab), administered once every 3 weeks (Q3w). |
| Control group | Active comparator | Drug: Capecitabine, Drug: Bevacizumab, Drug: Oxaliplatin injectionControl group: Capox + Bev, administered once every 3 weeks (Q3w), for a maximum of 8 cycles. Then, it entered the maintenance treatment stage with Capecitabine + Bev, administered once every 3 weeks (Q3w). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The subjects were able to understand the informed consent form, voluntarily participated and signed the informed consent form;
- On the day of signing the informed consent form, the subjects were aged between 18 and 75 years old, regardless of gender;
- Pathological tissue diagnosis confirmed rectal adenocarcinoma (including signet ring cell carcinoma and mucinous adenocarcinoma);
- The lower boundary of the lesion was within 15 cm from the anal verge;
- The clinical stage was stage IV;
Key exclusion criteria (10 listed)
- Subjects with untreated active brain metastases or meningeal metastases; if the brain metastases of the subject have been treated and the condition of the metastases is stable (brain imaging examination at least 4 weeks before the first administration shows stable lesions, and there are no new neurological symptoms or the neurological symptoms have recovered to baseline levels), and there is no evidence of new onset or enlargement of the metastases, they are allowed to be enrolled; (2) Have the following cardiovascular conditions:
- Active coronary heart disease with angina pectoris or patients who need to take medication to prevent angina attacks;
- NYHA II-IV grade chronic heart failure;
- Uncontrolled hypertension after drug treatment (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
- Major vascular diseases (such as aortic aneurysm, aortic dissection aneurysm, internal carotid artery stenosis);
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 |
|---|---|---|
| Iparomlimab and TuvonralimabAlso: QL1706(Experimental group) PD-1/CTLA-4 Antibody | Drug | Experimental group |
| Radiotherapy to the primary site(Experimental group) Radiotherapy to the primary site of rectal | Radiation | Experimental group |
| Capecitabine(both groups) | Drug | Control group, Experimental group |
| Bevacizumab(both groups) | Drug | Control group, Experimental group |
| Oxaliplatin injection(both groups) | Drug | Control group, Experimental group |
Primary outcome
12-month disease-free survival rate (progression-free survival rate, PFSR)
Time frame: From randomization to disease progression or death from any cause, whichever occurs first; the progression-free survival rate will be estimated at 12 months.
7 secondary outcomes
Objective response rate (ORR)
Time frame: From randomization to the first documented tumor response, assessed during the entire treatment period and follow-up, up to 24 months.
Disease control rate (DCR)
Time frame: From randomization to the first documented tumor response, assessed during the entire treatment period and follow-up, up to 24 months.
Time to response (TTR)
Time frame: From randomization to the first documented objective response (complete or partial response), assessed up to 24 months.
Duration of response (DOR)
Time frame: From the first documented objective response (CR or PR) to disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
6-month progression-free survival rate (PFSR)
Time frame: From randomization to disease progression or death from any cause, whichever occurs first; the progression-free survival rate will be estimated at 6 months.
Progression-free survival (PFS)
Time frame: From randomization to disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Overall survival (OS)
Time frame: From randomization to death from any cause, assessed up to 24 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 3 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iparomlimab and Tuvonralimab, Radiotherapy to the primary site and Capecitabine in people with Rectal Neoplasms Malignant, run by Peking University Cancer Hospital & Institute.
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 14 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: opening soon, as of the sponsor's last update on 3 Feb 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?
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?
12-month disease-free survival rate (progression-free survival rate, PFSR) (time frame: From randomization to disease progression or death from any cause, whichever occurs first; the progression-free survival rate will be estimated at 12 months.). 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 3 Feb 2026.