Health TrialsbyHealthPanel

QL1706 Combined With SOX Used in Theperioperative Treatment

ConditionsGastric CancersEsophagogastric Junction Cancers
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXiangdong Cheng

About this trial

This is a single-center, single-arm clinical study to evaluate the efficacy and safety of QL1706 combined with SOX for the treatment of resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.

The study consists of the following two phases:

Phase 1: The safety introduction phase of QL1706 combined with SOX, using a 3+3 design, enrolled about 6 to 12 patients with locally advanced gastric/gastroesophageal junction adenocarcinoma (primary clinical stage ≥T3 or N+, M0) and underwent 3-week DLT evaluation.

Phase 2: This phase plans to enroll 42 to 45 patients, using investigator-evaluated pCR as the primary endpoint. QL1706 is administered by intravenous infusion of RP2D as defined in Part 1 starting from cycle 1.

Preoperative QL1706 RP2D combined with SOX (3 cycles) → radical surgery (D2) → postoperative QL1706 RP2D combined with SOX (5 cycles) → postoperative maintenance of QL1706 RP2D (up to 1 year before and after surgery); neoadjuvant therapy Surgery should be performed within 3 to 6 weeks after the last dosing, with a minimum interval of 4 weeks after surgery and a maximum interval of 6 weeks recommended for postoperative adjuvant therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign a written informed consent to join the study voluntarily;

Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction;

Adenocarcinoma of the stomach or gastroesophageal junction was evaluated by CT/MRI (primary clinical stage ≥T3 or N+, M0, according to AJCC 8th edition staging), including Siewert type II and III tumors

Age 18-75 years old, male or female;

Disqualifiers

There are unresectable factors, including unresectable tumor causes or unresectable or refused surgery contraindications;

any radiation therapy, chemotherapy, or immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) and other anti-tumor drugs;

being treated with immunosuppressive drugs or systemic hormones for immunosuppressive purposes within 2 weeks prior to the initial use of the investigational drug (dose >10mg/ day prednisone or equivalent); In the absence of active autoimmune disease, inhaled or topical steroid use and adrenocortical hormone replacement with doses >10mg/ day of prednisone or equivalent are permitted;

Received live attenuated vaccine within 4 weeks prior to the first use of the investigational drug; If enrolled, subjects must not receive live vaccine during the study period or within 120 days after the last administration of QL1706;

Trial design

Design model

Single group

Treatments tested in this trial

  • QL1706 combined with SOX

    Drug

    QL1706 + SOX (3 cycles) before surgery → radical surgery (D2) → QL1706 + SOX (5 cycles) after surgery → QL1706 monotherapy maintenance （up to 1 year before and after surgery); Phase 1 (initial dose cohort) ： QL1706 5mg/kg ；Phase 1 (dose escalation cohort)：QL1706 7.5mg/kg ；Phase 2：QL1706 RP2D

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: QL1706 combined with SOXExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity

Time frame
21 days
2

Recommended Phase II Dose

Time frame
21 days
3

Pathological complete response

Time frame
After operation about 2 weeks

Secondary outcomes

1

major pathological response

Time frame
After operation about 2 weeks
2

R0 resection rate

Time frame
about 15 weeks
3

ypTNM stage

Time frame
After operation about 2 weeks
4

Event-Free Survival

Time frame
up to approximately 4 years

Other outcomes

1

Correlation between biomarkers（Such as PD-L1 expression, MMR, EBV and HER2 status） and efficacy（Such as EFS、DFS））

Time frame
up to approximately 6 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiangdong Cheng

Lead sponsor

Zhejiang Cancer Hospital

Sponsor institution

Source ClinicalTrials.gov
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