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RecruitingNCT07866313Updated Oct 8, 2026

Neoadjuvant Chemoradiotherapy Combined With QL1706 for MSS-Type Low-Rectal Cancer

A Phase 2/3 interventional study of Neoadjuvant short-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab and Neoadjuvant long-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab in MSS-type Low Rectal Cancer，Neoadjuvant Chemoradiotherapy, QL1706, sponsored by Changhai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Changhai Hospital · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • MSS-type Low Rectal Cancer，Neoadjuvant Chemoradiotherapy, QL1706
03

In context

Lead sponsor

Changhai Hospital is the lead sponsor of 354 studies on the registry; 136 are open to participants now.

Browse Changhai Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Early rectal cancer at a low stage（cT1-3N0M0）

    Drug: Neoadjuvant short-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab

  • Experimental
    Low-stage locally advanced rectal cancer (cT4N0M0 or cTanyN+M0)

    Drug: Neoadjuvant long-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab

Interventions

  • DrugNeoadjuvant short-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab

    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.

  • DrugNeoadjuvant long-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab

    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.

06

What researchers measure

Primary outcomes

  1. The rate of CR

    :Rate of patients who achieve complete remission（cCR rate +pCR rate）

    Time frame: Up to 24 months

Secondary outcomes

  1. 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.

    Time frame: Up to 36 months

  2. 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.

    Time frame: Up to 36 months

  3. 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.

    Time frame: Up to 60 months

  4. 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.

    Time frame: Up to 60 months

  5. 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)

    Time frame: Up to 24 months

07

Study locations

1 of 1 sites recruiting
  • Shanghai Changhai Hospital
    Shanghai, Shanghai Municipality 210000, China
    Recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2026 (actual). Primary completion is estimated for Aug 2028, 26 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2026
First posted
Oct 8, 2026
StartActual
Jun 1, 2026
Primary completionEst.
Aug 1, 2028
CompletionEst.
Dec 1, 2031
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07866313
Lead sponsor
Changhai Hospital
Responsible party
Wei Zhang (Department Director，professor, Changhai Hospital) — Principal investigator
First posted
Oct 8, 2026
Start date
Jun 1, 2026
Primary completion
Aug 1, 2028 (estimated)
Completion
Dec 1, 2031 (estimated)
Last update
Oct 8, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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