MSS-type Low Rectal Cancer，Neoadjuvant Chemoradiotherapy, QL1706Phase 2/3NCT07866313
Neoadjuvant Chemoradiotherapy Combined With QL1706 for MSS-Type Low-Rectal Cancer
A Phase 2/3 study testing Neoadjuvant short-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab and Neoadjuvant long-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab in people with MSS-type Low Rectal Cancer，Neoadjuvant Chemoradiotherapy, QL1706, run by Changhai Hospital at 1 site in China.
Trial summary
he goal of this prospective, exploratory clinical trial is to learn if neoadjuvant chemoradiotherapy combined with QL1706 (a dual PD-1/CTLA-4 antibody) can effectively treat in patients with MSS-type low rectal cancer (tumor lower edge ≤ 7cm from the anal verge, aged 18-75). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MSS-type Low Rectal Cancer，Neoadjuvant Chemoradiotherapy, QL1706
- What is being tested?
- Neoadjuvant short-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab and Neoadjuvant long-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Dec 2031
- 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
- Willing to receive neoadjuvant therapy.
- Age 18-75 years; any gender.
- Histopathologically confirmed rectal adenocarcinoma.
- Low rectal cancer confirmed by colonoscopy, endoscopic ultrasound, and high-resolution pelvic MRI, with the tumor lower edge ≤7 cm from the anal margin and no distant metastases.
- Microsatellite stable (MSS) status determined by PCR-capillary electrophoresis, with all 5 loci stable.
- ECOG performance status 0-1.
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- Adequate laboratory values:
- White blood cell count ≥3.5×10^9/L, absolute neutrophil count ≥1.8×10^9/L, platelet count ≥100×10^9/L, and hemoglobin ≥100 g/L.
- INR ≤1.5 and APTT ≤1.5× upper limit of normal (ULN), or partial prothrombin time (PTT) ≤1.5× ULN.
- Total bilirubin ≤1.25× ULN; ALT and AST ≤5× ULN.
- 24-hour creatinine clearance ≥50 mL/min or serum creatinine ≤1.5× ULN.
- Voluntary signed informed consent.
Who cannot join
- History of malignant colorectal tumors.
- Intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery.
- Known allergy to capecitabine, oxaliplatin, PD-L1 antibodies, CTLA-4 antibodies, or similar drugs.
- Pathology indicating poorly differentiated adenocarcinoma or signet-ring cell carcinoma.
- Any unstable systemic disease, including but not limited to severe infection, uncontrolled diabetes, medication-uncontrolled hypertension, unstable angina, cerebrovascular accident or transient ischemic attack, myocardial infarction, congestive heart failure, serious arrhythmia requiring medical treatment, or hepatic, renal, or metabolic disease that may be life-threatening.
- Comorbidities or conditions (e.g., mental illness, alcoholism, or drug abuse) that may increase the risk of poor response to the investigational drug, affect compliance with trial requirements, or confound study results.
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- Receipt of any other investigational drug or participation in another interventional clinical trial within 30 days before screening.
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study; men or women unwilling to use effective contraception.
- Any other circumstance in which the investigator determines the patient is unsuitable for the clinical trial.
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
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 210000
Wei Principal Investigator, 86-13816321041, weizhang2000cn@163.com
About this study
Official title: A Prospective, Exploratory Study on the Efficacy of Neoadjuvant Chemoradiotherapy Combined With QL1706 in Patients With MSS-type Low-stage Rectal Cancer
he goal of this prospective, exploratory clinical trial is to learn if neoadjuvant chemoradiotherapy combined with QL1706 (a dual PD-1/CTLA-4 antibody) can effectively treat in patients with MSS-type low rectal cancer (tumor lower edge ≤ 7cm from the anal verge, aged 18-75). The main questions it aims to answer are:
What is the complete response (CR) rate, including clinical complete response (cCR) and pathological complete response (pCR)? What are the 3-year and 5-year overall survival (OS) and disease-free survival (DFS) rates?
Read more
Researchers will compare two cohorts of patients based on tumor stage (Cohort 1: early low rectal cancer cT1-3N0M0; Cohort 2: locally advanced low rectal cancer cT4N0M0 or cTanyN+M0) to see if the combination treatment yields different efficacy and safety outcomes depending on the disease stage.
Participants will:
Receive either short-course radiotherapy (25Gy/5 fractions) or long-course radiotherapy (50Gy/25 fractions) based on their assigned cohort.
Receive 4 cycles of chemotherapy (Capeox: Capecitabine + Oxaliplatin) combined with QL1706.
Undergo assessments including pelvic MRI, endorectal ultrasound, and digital rectal exams to evaluate tumor regression.
Based on the tumor response, undergo surgery (radical resection or local excision) or enter a Watch \& Wait follow-up protocol.
Provide blood, urine, stool, and tissue samples for biomarker and exploratory analyses.
- Being tested
- Neoadjuvant short-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab, Neoadjuvant long-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant short-term radiotherapy and chemotherapy + iparomlimab and tuvonralimabDrug
Short-course chemoradiotherapy was administered, with a total tumor dose of 25 Gy to the primary tumor and high-risk areas (5 Gy per session, 5 sessions in total). After completion of radiotherapy, a 2-week rest period was allowed. Following that, 4 cycles of Capoex combined with QL706 were given (every 3 weeks): On Day 1, QL706 was administered at 5 mg/kg via intravenous infusion; oxaliplatin was given at 130 mg/m² via intravenous infusion. From Day 1 to Day 14, capecitabine was taken orally at 850-1000 mg/m², twice daily.
Neoadjuvant long-term radiotherapy and chemotherapy + iparomlimab and tuvonralimabDrug
Long-term radiotherapy was administered to the primary tumor and high-risk areas, with a total dose of 50 Gy (2 Gy per session, 25 sessions in total). After completion of radiotherapy, a 2-week rest period was allowed. Following that, 4 cycles of Capoex combined with QL706 were administered (every 3 weeks): On Day 1, QL706 was given at a dose of 5 mg/kg via intravenous infusion; oxaliplatin was administered at a dose of 130 mg/m² via intravenous infusion from Day 1 to Day 14. Capecitabine was taken orally at a dose of 850-1000 mg/m², twice daily, from Day 1 to Day 14.
| Study group | Role | What they receive |
|---|---|---|
| Early rectal cancer at a low stage（cT1-3N0M0） | Experimental | Not described Receives: Drug: Neoadjuvant short-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab |
| Low-stage locally advanced rectal cancer (cT4N0M0 or cTanyN+M0) | Experimental | Not described Receives: Drug: Neoadjuvant long-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of CR
:Rate of patients who achieve complete remission（cCR rate +pCR rate）
Measured: Up to 24 months
Secondary outcomes (5)
Overall survival(OS)
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.
Measured: Up to 36 months
Disease free survival(DFS)
Disease-free survival (DFS) is defined as the time from randomization to the first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
Measured: Up to 36 months
Overall survival(OS)
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.
Measured: Up to 60 months
Disease free survival(DFS)
Disease-free survival (DFS) is defined as the time from randomization to the first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
Measured: Up to 60 months
Wexner Incontinence Score（WIS）
Assess the severity of fecal incontinence (anal incontinence), evaluate the patient's ability to control bowel movements, and determine the impact of incontinence on the quality of life.
0 points: The defecation control function is normal. 1-4 points: Fair control over bowel movements (mild incontinence). 5-9 points: Moderate incontinence.
≥10 points: Severe incontinence (the higher the score, the more severe the incontinence and the worse the ability to control bowel movements)
Measured: 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 posted8 Oct 2026
- Study start1 Jun 2026
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MSS-type Low Rectal Cancer，Neoadjuvant Chemoradiotherapy, QL1706Studies of the same condition, open and under way.
- More trials run by Changhai 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866313
- Sponsor's protocol ID
- CHOICE V
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Exploratory Study on the Efficacy of Neoadjuvant Chemoradiotherapy Combined With QL1706 in Patients With MSS-type Low-stage Rectal Cancer
- ClinicalTrials.gov ID
- NCT07866313
- Acronym / sponsor ID
- CHOICE V
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 8 Oct 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.
he goal of this prospective, exploratory clinical trial is to learn if neoadjuvant chemoradiotherapy combined with QL1706 (a dual PD-1/CTLA-4 antibody) can effectively treat in patients with MSS-type low rectal cancer (tumor lower edge ≤ 7cm from the anal verge, aged 18-75). The main questions it aims to answer are:
What is the complete response (CR) rate, including clinical complete response (cCR) and pathological complete response (pCR)? What are the 3-year and 5-year overall survival (OS) and disease-free survival (DFS) rates?
Researchers will compare two cohorts of patients based on tumor stage (Cohort 1: early low rectal cancer cT1-3N0M0; Cohort 2: locally advanced low rectal cancer cT4N0M0 or cTanyN+M0) to see if the combination treatment yields different efficacy and safety outcomes depending on the disease stage.
Participants will:
Receive either short-course radiotherapy (25Gy/5 fractions) or long-course radiotherapy (50Gy/25 fractions) based on their assigned cohort.
Receive 4 cycles of chemotherapy (Capeox: Capecitabine + Oxaliplatin) combined with QL1706.
Undergo assessments including pelvic MRI, endorectal ultrasound, and digital rectal exams to evaluate tumor regression.
Based on the tumor response, undergo surgery (radical resection or local excision) or enter a Watch \& Wait follow-up protocol.
Provide blood, urine, stool, and tissue samples for biomarker and exploratory analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early rectal cancer at a low stage（cT1-3N0M0） | Experimental | Drug: Neoadjuvant short-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab |
| Low-stage locally advanced rectal cancer (cT4N0M0 or cTanyN+M0) | Experimental | Drug: Neoadjuvant long-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Willing to receive neoadjuvant therapy.
- Age 18-75 years; any gender.
- Histopathologically confirmed rectal adenocarcinoma.
- Low rectal cancer confirmed by colonoscopy, endoscopic ultrasound, and high-resolution pelvic MRI, with the tumor lower edge ≤7 cm from the anal margin and no distant metastases.
- Microsatellite stable (MSS) status determined by PCR-capillary electrophoresis, with all 5 loci stable.
Key exclusion criteria (9 listed)
- History of malignant colorectal tumors.
- Intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery.
- Known allergy to capecitabine, oxaliplatin, PD-L1 antibodies, CTLA-4 antibodies, or similar drugs.
- Pathology indicating poorly differentiated adenocarcinoma or signet-ring cell carcinoma.
- Any unstable systemic disease, including but not limited to severe infection, uncontrolled diabetes, medication-uncontrolled hypertension, unstable angina, cerebrovascular accident or transient ischemic attack, myocardial infarction, congestive heart failure, serious arrhythmia requiring medical treatment, or hepatic, renal, or metabolic disease that may be life-threatening.
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 |
|---|---|---|
| Neoadjuvant short-term radiotherapy and chemotherapy + iparomlimab and tuvonralimabShort-course chemoradiotherapy was administered, with a total tumor dose of 25 Gy to the primary tumor and high-risk areas (5 Gy per session, 5 sessions in total). After completion of radiotherapy, a 2-week rest period was allowed. Following that, 4 cycles of Capoex combined with QL706 were given (every 3 weeks): On Day 1, QL706 was administered at 5 mg/kg via intravenous infusion; oxaliplatin was given at 130 mg/m² via intravenous infusion. From Day 1 to Day 14, capecitabine was taken orally at 850-1000 mg/m², twice daily. | Drug | Early rectal cancer at a low stage（cT1-3N0M0） |
| Neoadjuvant long-term radiotherapy and chemotherapy + iparomlimab and tuvonralimabLong-term radiotherapy was administered to the primary tumor and high-risk areas, with a total dose of 50 Gy (2 Gy per session, 25 sessions in total). After completion of radiotherapy, a 2-week rest period was allowed. Following that, 4 cycles of Capoex combined with QL706 were administered (every 3 weeks): On Day 1, QL706 was given at a dose of 5 mg/kg via intravenous infusion; oxaliplatin was administered at a dose of 130 mg/m² via intravenous infusion from Day 1 to Day 14. Capecitabine was taken orally at a dose of 850-1000 mg/m², twice daily, from Day 1 to Day 14. | Drug | Low-stage locally advanced rectal cancer (cT4N0M0 or cTanyN+M0) |
Primary outcome
The rate of CR
Time frame: Up to 24 months
:Rate of patients who achieve complete remission（cCR rate +pCR rate）
5 secondary outcomes
Overall survival(OS)
Time frame: Up to 36 months
Disease free survival(DFS)
Time frame: Up to 36 months
Overall survival(OS)
Time frame: Up to 60 months
Disease free survival(DFS)
Time frame: Up to 60 months
Wexner Incontinence Score（WIS）
Time frame: 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 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Neoadjuvant short-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab and Neoadjuvant long-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab in people with MSS-type Low Rectal Cancer，Neoadjuvant Chemoradiotherapy, QL1706, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 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 8 Oct 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of CR (time frame: Up to 24 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 8 Oct 2026.