Neoadjuvant Radiochemotherapy Combined With QL1706 for Low Rectal Cancer

April 9, 2025 updated by: Wei Zhang, Changhai Hospital

Neoadjuvant Radiochemotherapy Combined With QL1706 for MSS-type Low Rectal Cancer: a Prospective, Exploratory, Multicohort Study

This study investigates the efficacy of neoadjuvant radiotherapy combined with QL1706 in MSS-type low-grade rectal cancer. This study is a prospective multicohort study, with cohort 1 intended to include patients with low grade early rectal cancer (cT1-3N0M0) and cohort 2 intended to include patients with low grade locally advanced rectal cancer (cT4N0M0 or cTanyN+M0). Each cohort included 30 subjects receiving neoadjuvant radiotherapy combined with QL1706 treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients willing to receive neoadjuvant therapy.
  2. Aged 18-75 years, regardless of gender.
  3. Diagnosed with low-lying rectal adenocarcinoma (tumor located ≤7 cm from the anal verge) via colonoscopy, endorectal ultrasound, and pelvic high-resolution MRI, without distant metastasis.
  4. Histopathologically confirmed rectal adenocarcinoma.
  5. Good patient compliance, able to attend follow-up visits as required.
  6. ECOG performance status score of 0-1.

  7. Laboratory tests meeting the following criteria:

    i. WBC ≥3.5×10^9/L, ANC ≥1.8×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥100 g/L.

    ii. INR ≤1.5, APTT ≤1.5×ULN, or PTT ≤1.5×ULN. iii. Total bilirubin ≤1.25×ULN; ALT/AST ≤5×ULN. iv. 24-hour creatinine clearance ≥50 mL/min or serum creatinine ≤1.5×ULN.

  8. Voluntary signed informed consent.

Exclusion Criteria:

  1. History of malignant colorectal tumors.
  2. Patients requiring emergency surgery (e.g., intestinal obstruction, perforation, or hemorrhage).
  3. Known allergy to capecitabine, oxaliplatin, PD-L1 inhibitors, CTLA-4 inhibitors, or related drugs.
  4. Histopathology indicating poorly differentiated adenocarcinoma or signet ring cell carcinoma.

  5. Unstable systemic diseases, including but not limited to:

    Severe infection, uncontrolled diabetes, refractory hypertension, unstable angina, cerebrovascular accident, myocardial infarction, congestive heart failure, life-threatening arrhythmias, or severe hepatic/renal/metabolic disorders.

  6. Conditions (e.g., psychiatric disorders, substance abuse) that may increase treatment risk, compromise compliance, or confound study results.
  7. Participation in another interventional clinical trial or use of investigational drugs within 30 days prior to screening.
  8. Pregnancy, lactation, or refusal to use effective contraception during the study.
  9. Other conditions deemed unsuitable by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort1
Patients with low rectal cancer, clinical stage cT1-3N0M0
Combination product: SCRT+Capoex+QL706
Using a short-course radiotherapy treatment protocol, the primary tumor and high-risk areas were irradiated with a tumor dose of 25 Gy (5 Gy/treatment × 5 treatments); 2 weeks of rest after the end of radiotherapy were followed by 4 cycles of Capoex combined with QL706.
Experimental: Cohort2
Patients with low locally advanced rectal cancer with clinical stage cT4N0M0 or cTanyN+M0
Combination product: LCRT+Capoex+QL706
Using a long course radiotherapy treatment protocol, the primary tumor and high-risk areas were irradiated with a tumor dose of 50 Gy (2 Gy/treatment x 25 treatments); a 2-week break at the end of radiotherapy was followed by 4 cycles of Capoex combined with QL706.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate
Time Frame: After neoadjuvant therapy 1 month or after surgery 1 month
Includes clinical complete response rate (cCR) and pathologic complete response rate (pCR)
After neoadjuvant therapy 1 month or after surgery 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years /5 years
Overall survival
3 years /5 years
Disease Free survival
Time Frame: 3 years /5 years
Disease Free survival
3 years /5 years
Wexner Fecal Incontinence Score (Wexner Score)
Time Frame: After neoadjuvant therapy 3 months or after surgery 3 months
Evaluates the severity of fecal incontinence (frequency and type). Includes frequency of solid/liquid/gas incontinence, need for pad use, and impact on daily life. Total score ranges from 0-20; higher scores indicate more severe incontinence (0 = full control, 20 = complete incontinence).
After neoadjuvant therapy 3 months or after surgery 3 months
Low Anterior Resection Syndrome Score (LARS Score)
Time Frame: After neoadjuvant therapy 3 months or after surgery 3 months
Assesses bowel dysfunction (LARS syndrome) in patients after low anterior resection for rectal cancer. Includes abnormal bowel frequency, urgency/incontinence, fragmented defecation, and difficulty emptying the bowel. Total score ranges from 0-42, categorized as no LARS (0-20), minor LARS (21-29), or major LARS (≥30). Higher scores indicate worse symptoms; lower scores are better.
After neoadjuvant therapy 3 months or after surgery 3 months
Short-Form 36 Health Survey (SF-36 Score )
Time Frame: After neoadjuvant therapy 3 months or after surgery 3 months
Broadly evaluates quality of life across eight domains: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain is scored 0-100; higher scores reflect better health in that domain. Higher total scores are better (100 = optimal health status).
After neoadjuvant therapy 3 months or after surgery 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2035

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRQ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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