Rectal CancerEarly Phase 1NCT06931873
Neoadjuvant Radiochemotherapy Combined With QL1706 for Low Rectal Cancer
A Early Phase 1 study testing SCRT+Capoex+QL706 and LCRT+Capoex+QL706 in people with Rectal Cancer, run by Changhai Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- SCRT+Capoex+QL706 and LCRT+Capoex+QL706
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2025to 1 Mar 2035
- Phase
- Early Phase 1
- 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
- Patients willing to receive neoadjuvant therapy.
- Aged 18-75 years, regardless of gender.
- 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.
- Histopathologically confirmed rectal adenocarcinoma.
- Good patient compliance, able to attend follow-up visits as required.
- ECOG performance status score of 0-1.
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- Laboratory tests meeting the following criteria:
- WBC ≥3.5×10^9/L, ANC ≥1.8×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥100 g/L.
- 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.
- Voluntary signed informed consent.
Who cannot join
- History of malignant colorectal tumors.
- Patients requiring emergency surgery (e.g., intestinal obstruction, perforation, or hemorrhage).
- Known allergy to capecitabine, oxaliplatin, PD-L1 inhibitors, CTLA-4 inhibitors, or related drugs.
- Histopathology indicating poorly differentiated adenocarcinoma or signet ring cell carcinoma.
- 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.
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- Conditions (e.g., psychiatric disorders, substance abuse) that may increase treatment risk, compromise compliance, or confound study results.
- Participation in another interventional clinical trial or use of investigational drugs within 30 days prior to screening.
- Pregnancy, lactation, or refusal to use effective contraception during the study.
- Other conditions deemed unsuitable by the investigator.
About this study
Official title: 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.
- Conditions
- Rectal Cancer
- Being tested
- SCRT+Capoex+QL706, LCRT+Capoex+QL706
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCRT+Capoex+QL706Combination product
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.
LCRT+Capoex+QL706Combination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort1 | Experimental | Patients with low rectal cancer, clinical stage cT1-3N0M0 Receives: Combination Product: SCRT+Capoex+QL706 |
| Cohort2 | Experimental | Patients with low locally advanced rectal cancer with clinical stage cT4N0M0 or cTanyN+M0 Receives: Combination Product: LCRT+Capoex+QL706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
Includes clinical complete response rate (cCR) and pathologic complete response rate (pCR)
Measured: After neoadjuvant therapy 1 month or after surgery 1 month
Secondary outcomes (5)
Overall survival
Overall survival
Measured: 3 years /5 years
Disease Free survival
Disease Free survival
Measured: 3 years /5 years
Wexner Fecal Incontinence Score (Wexner Score)
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).
Measured: After neoadjuvant therapy 3 months or after surgery 3 months
Low Anterior Resection Syndrome Score (LARS Score)
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.
Measured: After neoadjuvant therapy 3 months or after surgery 3 months
Short-Form 36 Health Survey (SF-36 Score )
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).
Measured: After neoadjuvant therapy 3 months or after surgery 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start20 May 2025 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-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
- NCT06931873
- Sponsor's protocol ID
- NCRQ
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 17 Apr 2025
- 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 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Radiochemotherapy Combined With QL1706 for MSS-type Low Rectal Cancer: a Prospective, Exploratory, Multicohort Study
- ClinicalTrials.gov ID
- NCT06931873
- Acronym / sponsor ID
- NCRQ
- Conditions
- Rectal Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2035 (estimated)
- First posted
- 17 Apr 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort1 | Experimental | Combination Product: SCRT+Capoex+QL706Patients with low rectal cancer, clinical stage cT1-3N0M0 |
| Cohort2 | Experimental | Combination Product: LCRT+Capoex+QL706Patients with low locally advanced rectal cancer with clinical stage cT4N0M0 or cTanyN+M0 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients willing to receive neoadjuvant therapy.
- Aged 18-75 years, regardless of gender.
- 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.
- Histopathologically confirmed rectal adenocarcinoma.
- Good patient compliance, able to attend follow-up visits as required.
Key exclusion criteria (10 listed)
- History of malignant colorectal tumors.
- Patients requiring emergency surgery (e.g., intestinal obstruction, perforation, or hemorrhage).
- Known allergy to capecitabine, oxaliplatin, PD-L1 inhibitors, CTLA-4 inhibitors, or related drugs.
- Histopathology indicating poorly differentiated adenocarcinoma or signet ring cell carcinoma.
- Unstable systemic diseases, including but not limited to:
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 |
|---|---|---|
| SCRT+Capoex+QL706Using 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. | Combination product | Cohort1 |
| LCRT+Capoex+QL706Using 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. | Combination product | Cohort2 |
Primary outcome
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)
5 secondary outcomes
Overall survival
Time frame: 3 years /5 years
Disease Free survival
Time frame: 3 years /5 years
Wexner Fecal Incontinence Score (Wexner Score)
Time frame: 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
Short-Form 36 Health Survey (SF-36 Score )
Time frame: After neoadjuvant therapy 3 months or after surgery 3 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 17 Apr 2025.
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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 Early Phase 1 study testing SCRT+Capoex+QL706 and LCRT+Capoex+QL706 in people with Rectal Cancer, run by Changhai Hospital.
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 10 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 17 Apr 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Complete Response Rate (time frame: After neoadjuvant therapy 1 month or after surgery 1 month). 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 17 Apr 2025.