Clinical trial · Interventional

Neoadjuvant Radiochemotherapy Combined With QL1706 for Low Rectal Cancer

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

NCT06931873CI-TRIAL-00088666not yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Rectal Cancer	Malignant Rectal Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
LCRT+Capoex+QL706	Combination Product	—	UNRESOLVED
SCRT+Capoex+QL706	Combination Product	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Cohort1
description
Patients with low rectal cancer, clinical stage cT1-3N0M0
interventionNames
1. Combination Product: SCRT+Capoex+QL706
type
EXPERIMENTAL
label
Cohort2
description
Patients with low locally advanced rectal cancer with clinical stage cT4N0M0 or cTanyN+M0
interventionNames
1. Combination Product: LCRT+Capoex+QL706

Primary outcomes (1)

measure
Complete Response Rate
timeFrame
After neoadjuvant therapy 1 month or after surgery 1 month

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.